St. Jude Medical Tendril MRI LPA1200M, Руководство пользователя

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A summary of the Events committee death classifications is shown in the table below.
Table 3. Events committee classification of patients deaths
Primary Cause Number of Patients
Cardiac: Arrhythmic 4
Cardiac: Ischemic 1
Cardiac: Pump Failure 4
Cardiac: Unknown 1
Non-Cardiac 40
Unknown 6
TOTAL 56
Potential Adverse Events
Possible adverse events associated with the system, include, but are not limited to the following:
MRI system adverse events:

Lead electrode heating and tissue damage resulting in loss of sensing or capture or both

Lead heating resulting in thrombus formation or embolism

Pulmonary embolism

Device heating resulting in tissue damage in the implant pocket or patient discomfort or both

Induced currents on leads resulting in continuous capture, VT/VF, hemodynamic collapse,
or all three

Damage to the device or leads causing the system to fail to detect or treat irregular
heartbeats or causing the system to treat the patient's condition incorrectly

Damage to the functionality or mechanical integrity of the device resulting in the inability to
communicate with the device

Movement or vibration of the device or leads

Lead dislodgment

Competitive pacing and potential for VT/VF induction if asynchronous pacing is programmed
when MRI Settings are enabled

Syncope due to loss of pacing if no pacing support is programmed with MRI settings

Death due to untreated spontaneous arrhythmia because tachy therapy is disabled when
MRI settings are programmed.
Potential system adverse events:

Air embolism

Body rejection phenomena

Cardiac tamponade or perforation

Hematoma, bleeding hematoma, seroma

Formation of fibrotic tissue; local tissue reaction

Inability to interrogate or program due to programmer or device malfunction

Infection/erosion

Interruption of desired pulse generator function due to electrical interference either