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Cardiac Airbag Technical Manual  

13

 

1.5 Adverse Events 

1.5.1  Potential Adverse Events 

The following is a list of the potential risks that may occur with 
this device: 

•

  Acceleration of arrhythmias 

•

 Air 

embolism 

•

 Bleeding 

•

  Chronic nerve damage 

•

 Erosion 

•

  Excessive fibrotic tissue growth 

•

 Extrusion 

•

 Fluid 

accumulation 

•

  Formation of hematomas or cysts 

•

  Inappropriate shocks  

•

 Infection 

•

 Keloid 

formation 

•

  Lead abrasion and discontinuity 

•

  Lead migration / dislodgment 

•

 Myocardial 

damage 

•

 Pneumothorax 

•

  Shunting current or insulating myocardium during 

defibrillation with internal or external paddles 

•

  Potential mortality due to inability to defibrillate or pace 

•

 Thromboemboli 

•

 Venous 

occlusion 

•

  Venous or cardiac perforation 

Содержание Cardiac Airbag

Страница 1: ...Draft Cardiac Airbag Cardiac Airbag T Family of Implantable Cardioverter Defibrillators and Software Cartridge for TMS 1000PLUS and EPR 1000PLUS Technical Manual...

Страница 2: ...T Implantable Cardioverter Defibrillator Inside the housing top left hand side Year of manufacture X Ray identification EI CAUTION Federal U S A law restricts this device to sale by or on the order of...

Страница 3: ...veillance EAS 12 1 4 10 Home Appliances 12 1 5 Adverse Events 13 1 5 1 Potential Adverse Events 13 1 5 2 Observed Adverse Events 14 1 6 Clinical Studies 17 1 6 1 Patients Studied 17 1 6 2 Methods 18 1...

Страница 4: ...ost Shock Pacing 33 2 6 Special Features 33 2 6 1 Home Monitoring Cardiac Airbag T Only 33 2 6 2 Real time IEGM Transmission 37 2 6 3 Capacitor Reformation 37 2 6 4 Patient and Implant Data 38 2 6 5 S...

Страница 5: ...6 5 9 Suggested Cardiac Airbag Implant Procedure 57 6 Follow up Procedures 68 6 1 General Considerations 68 6 2 Suggested Cardiac Airbag Follow Up Procedure 68 6 3 Longevity 74 6 3 1 Standard ERI Meth...

Страница 6: ...6 3 Volts Maximum Shock Energy 30 joules Defibrillation Lead Ports Two DF 1 3 2 mm Pacing Lead Ports One IS 1 3 2 mm Dimension 55 x 67 x 13 mm Volume 39 cc Mass 73 g Housing Material Titanium Header...

Страница 7: ...s of single channel IEGM storage available to record spontaneous and induced ventricular tachyarrhythmias The Cardiac Airbag is restricted to storage of diagnostic information up to and including 3 tr...

Страница 8: ...These programmers are used to interrogate and program the ICDs In addition the programmer software is used to perform the interrogation and programming of the ICDs during implant and follow up testing...

Страница 9: ...potentially hazardous leakage currents Lead Systems The use of another manufacturer s I system may cause potential adverse consequences such as under sensing of cardiac activity and failure to deliver...

Страница 10: ...influx and possible shunting of high energy therapy Capacitor Reformation Infrequent charg capacitors may extend the charge times of the ICD The capacitors may be reformed manually or the ICD may be...

Страница 11: ...mmers to communicate with the device TMS 1000 PLUS or EPR 1000 PLUS Sealing Sy m ste Failure to properly insert the torque wrench ld Be aware that the changes in the hocks may be withheld if preparing...

Страница 12: ...ramming wand immediately to restore the permanent program EP Test Functions Ensure that cardiac resuscitation equipment is available during all EP Test Function operations Physicians should be trained...

Страница 13: ...as failure to do so may result in damage to the lead s and or difficulty connecting lead s Cross Threading Setscrew s To prevent cross threading the setscrew s do not back the setscrew s completely o...

Страница 14: ...m may as a result generate false system status information for the implant Impedance Measurement During the impedance measurement with high stimulation amplitudes nerve or skeletal muscles may be brie...

Страница 15: ...n and prior to performing any of the following medica addition the ICD should be checked after the procedures to assure proper programming Diathermy Diathermy therapy is not recommended for ICD patien...

Страница 16: ...ddles as far as possible away from the implanted device and lead system After delivery of an external defibrillation shock interrogate the ICD to confirm device status and proper function Lithotripsy...

Страница 17: ...y be a potential interaction between cellular phones and BIOTRONIK ICD systems Potential effects may be due to either the cellular phone signal or the magnet within the telephone and may include inhib...

Страница 18: ...raction of EMI with implanted ICDs is not possible due to the disparate nature of EMI 1 4 9 Electronic Article Surveillance EAS Equipment such as retail theft prevention systems may interact with puls...

Страница 19: ...ssive fibrotic tissue growth Extrusion Fluid accumulation Formation of hematomas or cysts Inappropriate shocks Infection Keloid formation Lead abrasion and discontinuity Lead migration dislodgment Myo...

Страница 20: ...This clinical study was performed with the Phylax XM and Phylax 06 ICDs which are earlier versions of the Cardiac Airbag ICDs The observed adverse events are applicable because the Cardiac Airbag ICD...

Страница 21: ...t result in invasive intervention injury or death Table 1 Reported Adverse Events AEs Number of Patients 154 Number of Patient Years 107 1 Event of pts with AEs of pts with AEs of AEs AE pt yrs Compli...

Страница 22: ...lt ca r c rgi tachyarrhythmia detection As a result appropriate 2 of the sue lated t ov ent o toggle during hig age pacito ha ng or therapy was not delivered in a timely manner The orientation of the...

Страница 23: ...uced programmable feature set Minor adjustments to therapy delivery options including no availability of ATP Reduced size from 69 cc to 39 cc Addition of Home Monitoring functionality The rate adaptiv...

Страница 24: ...te The primary endpoint of the study was to evaluate the ventricular tachyarrhythmia conversion rate Patients underwent standard ICD implantation and then were evaluated at predischarge and regular fo...

Страница 25: ...l number of patients 5 2 8 154 2 3 10 0 Appropriate Sensing and Pacing Rate2 98 0 703 717 96 8 98 9 1 Conversion data were collected in the clinical study for both induced and spontaneous tachyarrhyth...

Страница 26: ...regnancy If there is a need to image the device care should be taken to minimize radiation exposure to the fetus and the mother Nursing Mothers Although appropriate biocompatibility testing has been c...

Страница 27: ...D Patients The prospective ICD implant candidate should undergo a cardiac evaluation to classify any and all tachyarrhythmias In addition other patient specific cardiac information will help in select...

Страница 28: ...itry have been optimized to ensure appropriate sensing during all potential cardiac rhythms Cardiac signals vary in amplitude therefore detection thresholds cannot be static The Automatic Sensitivity...

Страница 29: ...er configuration is only accessed by code and is not available in the US Typically the upper threshold UT is reset with each sensed ot occur during The UT is set at 50 of the measured R wave for the S...

Страница 30: ...Sensitivity Con w period the UT is set to 3 0 mV After the T wave discrimination period the threshold is further reduced to 1 5 mV Both the Upper and Lower Thresholds decay over time but the Minimum T...

Страница 31: ...ricular tachyarrhythmias Each detected ventricular tachyarrhythmia is clas entricular Fibrillation VF zone limit 2 2 V The Cardiac Airbag ICDs detect and measure the rate of sensed cardiac signals to...

Страница 32: ...ble VT rate classifications The Interval Counter is the number of intervals required to declare a tachyarrhythmia as VT A ta must meet both the rate interval criteria and the preset Interval Counter i...

Страница 33: ...te between s increase and a ventricular tachycardia which typically begins with an abrupt rate change Onset criterion evaluates the most recently sensed cardiac intervals and compares it to the previo...

Страница 34: ...nd independent of the initial detection criteria 2 3 1 VT Redetection The Redetection Count is not programmable and remains independent of the initial dete Redetection of an ongoing tachyarrhythmia is...

Страница 35: ...rmation of the arrhythmia The remaining shock energies are non programma confirmation All shocks utiliz and normal polarity 2 4 1 1 Number of Shocks The number of shocks defines the total number of sh...

Страница 36: ...to 40 of the initial charge voltage the shock switches polarity At that point it discharges to 20 of the initial charge voltage before the w provides a pictorial representation of the biphasic wavefo...

Страница 37: ...ing rate to increasing or decreasing patient activity based on data collected from a motion sensor within the ICD Separate criteria controls the rate of increase and decrease of pacing as well as the...

Страница 38: ...se and Rate Decrease parameters work together with the Gain to determine how quickly pacing rate increases or decreases to occur with changes in the sensor output A rate increase of 2 ppm per second w...

Страница 39: ...this status is transmitted Further measurements and transmissions of Home Monitoring data are no longer possible 1 second the ICD will begin bradycardia therapy at the post shock pacing rate amplitud...

Страница 40: ...vice Figure The minimal distance between the 2 6 1 2 Patient Device 3 is designed for use in the home device and the associated a BIOTRONIK Service Center ual and is comprised of the mobile charging s...

Страница 41: ...t is titled depending on the type of event transmission This Cardio Report contains current and previous implant data The Cardio Report is sent to the attending physician via fax All reports use the s...

Страница 42: ...ta at an When certain cardiac and technical a repor ibed as an event message The following cardiac and technical events initiate Special device status errors VT Detected and terminated VF First ineffe...

Страница 43: ...in those hat do not regularly receive shock therapy The ICD is automatically re form the capacitors every 3 months The p eset following an automatic or manual capacitor reform or any device initiated...

Страница 44: ...ng and detection as programmed If a tachyarrhythmia is detected n the process is aborted and therapy is available if required 2 6 4 Patient and Implant Data input of data ent Throughout the reform dur...

Страница 45: ...tem status screen presents a large variety of information about the Cardiac Airbag ICDs including Serial number always displayed after interrogation End of Service Last charge event Date Energy Charge...

Страница 46: ...esented as a table of events with the most recent episode listed first Each IEGM segment can be viewed from the episode detail sub menu by selecting the EGM button From this screen an IEGM can be expa...

Страница 47: ...Redetection Delivered Shocks The ICD can store IEGMs for the following events prior to ERI 3 spontaneous VF episodes treated with shock therapy Non sustained VF episodes without shock thera 10 VT mon...

Страница 48: ...period of several seconds The frequency of the pulses and the duration of the Sho means aced stim lses Nu e ization interval R S1 and 2 6 7 Arrhythmia Induction Features Cardiac Airbag IC burst are de...

Страница 49: ...r and the shock command will be delivered upon selecting the OK button in this screen After each manual shock the EP test screen will display the shock energy lead impedance and charge time 2 6 9 Test...

Страница 50: ...ed to allow the user to be directed through the required program modules with the press of a single button Interrogation of the device Measurement of the battery status Interrogation of the episode co...

Страница 51: ...is presented below VT or deac y in the ICD The user ansmitted Interrogate ICD withou ta t select Skip Follow Up Interrog list d within the Parameter screen Main Function Keys VF Detection The VT VF D...

Страница 52: ...time setting of the programmer Holter Time Setting clears the date and time from the implant memory and sets the internal clock of the implant to the time of the programming is wing tabs t Each of co...

Страница 53: ...data from the open window 3 3 Parameter Window The Pa therapies pacing are completed from this Parameter screen see Figure 8 Detection and Therapy parameters are displayed only if VT VF Detection is...

Страница 54: ...48 Cardiac Airbag Technical Manual Figure 8 Parameter Window...

Страница 55: ...Cardiac Airbag Technical Manual 49...

Страница 56: ...product information label The label contains the model specifications technical data serial number use before date and sterilization and storage information The ICD and its accessories have been seal...

Страница 57: ...Cardiac Airbag Technical Manual 51...

Страница 58: ...ter PA 4 used to connect the PK 44 cable to sensing and pacing leads while the stylet is still inserted Perform an interrogation of the ICD Ensure programmer operation nominal device parameters and ba...

Страница 59: ...er of the outer oral region The device may be sue or in the muscle e etched side facing container as indicated by the arrow Do not contaminate the inner tray Take out the inner sterile tray by grippin...

Страница 60: ...se with a defibrillation lead systems having one IS 1 connector for ventricular sensing and pacing and up to two DF 1 connectors for delivery of shock therapy Figure 9 depicts the configuration of the...

Страница 61: ...il it is firmly placed in the setscrew Rotate the wrench counterclockwise until the receptacle is clear of obstruction Insert the lead connector into the connector port of the ICD without bending the...

Страница 62: ...conversion be done prior to closing the pocket This will ensure that the lead system has been securely connected to the device and has not changed position enclosed torque wrench through the perforat...

Страница 63: ...EPR 1000PLUS Ensure both the programmer date and time are correct To change 2 the date and time access 3 G cable and verify the signal before the patient is prepped and draped More Preferences PC Conn...

Страница 64: ...re 10 Performing a manual capacitor reformation 2 Formation See Figure 1 Press Options button Select Start 11 and then OK meter is 5 arge Time 3 During charging an ICD Charging displayed in the ICD St...

Страница 65: ...ons button 2 In the Programmer area press Implant List button to return to the main programmer screen 3 Select TMS 1000 from the test Implant List Connecting the ventricular lead for testing 1 Connect...

Страница 66: ...2 Press and hold the Record Data See Figure 12 button to measure the R wave amplitude There is an audible tone when the ICD has detected a sensed R wave 3 In general R wave amplitudes should be great...

Страница 67: ...ess Start Pacing to begin threshold testing at the displayed parame 4 Decrease Pulse Amplitudes See Figure 13 until loss of capture occurs rhythm 5 Press Stop Pacing to return to the patient s intrins...

Страница 68: ...nnecting the ICD to the leads 5 Verify VT VF Detection is disabled 6 Hand off the pre programmed ICD to the implanting physician 7 Disconnect the ventricular lead pins from the PK 44 cable and insert...

Страница 69: ...d e automatically verified 6 Check R wave Amplitudes greater than 5 mV Verify pac acceptable range 300 1000 Verify Battery Status is OK Perform a Pacing Threshold Press Resume Follow up to print out t...

Страница 70: ...wave or HF burst Press Print button to be 2 gin printing induction 3 Press Start VT VF Induction See Figure 14 and OK to induce VF 4 Observe the IEGM markers and ICD charging indicator on the program...

Страница 71: ...Read Shock Data is automatically updated with shock values 7 Press Print to print out the DFT Test Screen 8 Select Holter and review EGM to ensure proper sensing during VF 9 Repeat induction process...

Страница 72: ...g of the following parameters detection intervals pacing sensing and therapy 2 Select Transmit to permanently program final parameters 3 Verify VT VF Detection is Enabled 4 Select Parameter button and...

Страница 73: ...Cardiac Airbag Technical Manual 67...

Страница 74: ...with the physicians and the permanent program should be retransmitted to the ICD ACC AHA NASPE Guidelines recommend the physician perform a patient follow up visit every 3 months 6 2 Suggested Cardia...

Страница 75: ...activate the Follow Up Assistant program ensure that all boxes are checked 2 Press Start Follow Up located in the lower left corner of the screen This button begins the follow up procedure by performi...

Страница 76: ...re occurs 3 If desired turn Print Test ON to run paper during testing Press Start Test to begin threshold testing at displayed parameters Decrease Test Amp cing threshold 6 Press Stop Test Permanently...

Страница 77: ...t Printing and analyzing detailed Holter data information 1 Press the Holter See Figure 18 button to view episodes 2 From the Episode List select the episode EGM you wish to view and or print 3 Press...

Страница 78: ...ton 2 mplitudes greater than 5 mV 00 Check R A 3 Verify Pacing Impedance values are within an acceptable range 300 10 4 Verify Battery Status is OK Verifying remaining shocks to ERI 1 Press Status but...

Страница 79: ...ted VF episo occurred 5 At ERI contact your local BIOTRONIK representative Making parameter changes and obtaining final printouts changed and select the 3 Interrogate the device and print final summar...

Страница 80: ...he optimum time for ICD replacement a replacement indicator is provided that notifies the user that replacement within a certain period of time is required Upon reaching ERI the battery has enough ene...

Страница 81: ...reformations are equivalent to shocks The estimates associated with 0 pacing support assume the ICD is sensing an intrinsic sinus rhythm at a rate of 70 bpm Table 4 Longevity Estimates VVI Pacing Sup...

Страница 82: ...that receive shock therapy increment the treated VF episode count Any VF episode that is detected by the ICD and the resulting charge is aborted prior to receiving a shock does not count against the...

Страница 83: ...nitoring for at least three months and to deliver minimum of six high energy shocks The estimates associated with duration of ERI assume the ICD is sensing an intrinsic sinus rhythm at a rate of 70 bp...

Страница 84: ...ckaged in a bio hazard container These may be delivered to either the local BIOTRONIK representative or the BIOTRONIK home office for expert disposal Contact BIOTRONIK if you need assistance with retu...

Страница 85: ...Cardiac Airbag Technical Manual 79...

Страница 86: ...increment and z the largest value NOTE Values depicted in gray are preset in the ICD and are not programmable values Mechanical Properties Parameter Value Range Dimensions 67 x 55 x 13 mm Conducting...

Страница 87: ...n and Redetection Parameters for VF Zone Inte OFF 200 10 400 ms m rval Rate 150 300 bp Number of X 8 Number of Y 12 Termination Detection 12 in 16 Shock Therapy Parameter Value Range Number of Shocks...

Страница 88: ...Maximum Sensor Rate 100 125 ppm Sensor Gain 4 Sensor Threshold mean Rate Increase 2 ppm s Rate Decrease 0 4 ppm s Post Shock Bradycardia Therapy Parameter Value Range Mode VVI Rate 70 ppm Amplitude 7...

Страница 89: ...tions are prohibited Although this transmitter has been approved by the Federal ommunications Commission there is no guarantee that it will not receive interfer ion from this transmitter interference...

Страница 90: ...84 Cardiac Airbag Technical Manual...

Страница 91: ...vailable BIOTRONIK bipolar ICD lead systems or other lead systems with which it has been tested The Cardiac Airbag family of ICDs is mechanically compatible with IS 1 sensing pacing lead connectors DF...

Страница 92: ...Distributed by BIOTRONIK Inc 6024 Jean Road Lake Oswego OR 97035 5369 800 547 0394 24 hour 503 635 9936 FAX Manufactured by BIOTRONIK GmbH Co Woermannkehre 1 D 12359 Berlin M4088 A 3 03 Germany...

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