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c. Release of the deactivation valve may require greater
pressure than that used to cycle the device.
2. System pressure changes may occur over time if you
fill the balloon with radiopaque solution of incorrect
concentration. Follow the instructions in the Operating
Room Manual to prepare the radiopaque solution with the
correct concentration.
Adverse Events
A prospective clinical study was conducted to demonstrate the
safety and efficacy of the AMS 800 Urinary Control System. A
total of 87 patients were enrolled in the study and 85 patients
were implanted with the device. During the study, 26 patients
experienced 43 device related adverse events. Table 1 lists the
device related adverse events reported during the study.
This trial involved only devices without InhibiZone.
Table 1: AMS 800 Prospective
Clinical Study Device Related Adverse Events
Interventions*
Total
Patients
Events
None
Adverse Event Category Events with AE Resolved Reported Medical** Surgical
Impaired Device Function
7
6
4
2
2
4
Pain/Discomfort
6 5
4
3 3 1
Delayed Wound Healing
5
5
5
2
3
0
Bladder Spasms
2
2
0
0
2
0
Difficult Activation
2
2
2
1
1
0
Migration
3 3
1
2 0 1
Tissue Erosion
2
2
2
0
0
2
Difficult Deactivation
1
1
1
0
1
0
Infection
2 2
2
0 0 2
Recurrent Incontinence
3
3
3
1
0
2
Fistula Formation
1
1
1
0
0
1
Hematoma
1 1
1
0 1 0
Swelling
2 2
2
0 2 1
Hydrocele
1 1
1
0 1 1
Tissue Erosion/Infection
1
1
1
0
0
1
Patient Dissatisfaction
1
1
1
0
0
1
Positional Incontinence
1
1
0
1
0
0
Wound Infection
1
1
1
0
1
0
Urinary Retention
1
1
1
0
1
0
*Events may have been addressed with more than one type of intervention.
** Medical interventions included: medication, education, frequent device deactivation,
dressing changes and catheterization.
How Supplied and Storage
Store device in a clean, dry, dark area at room temperature.
WARNING:
Contents supplied STERILE. Do not use if
sterile barrier is damaged. If damage is found, call your AMS
representative.
For single patient use only. Do not reuse, reprocess or resterilize.
Reuse, reprocessing or resterilization may compromise the
structural integrity of the device and/or lead to device failure
which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of
contamination of the device and/or cause patient infection or
cross-infection, including, but not limited to, the transmission of
infectious disease(s) from one patient to another. Contamination
of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance with
hospital, administrative and/or local government policy.
Clinical Studies
The data from four (4) AMS 800 studies are presented:
(a) Prospective multi-center non-randomized clinical study,
(b) Retrospective patient information form (PIF) study,
(c) Retrospective clinical study, and
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