|
U.S. Registered Implants:
60,000 U.S. Approval Date: May 2008 U.S. Estimated Active Implants: 52,000 | U.S. Normal Battery Depletions:
28 U.S. Unconfirmed Reports of Premature Battery Depletion: 1 U.S. Malfunctions:60 Without Compromised Therapy:23 With Compromised Therapy:37 |
 |
 |
 |
| Year | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Non Advisory Population Registered Implants: 29000 | Depletions and Malfunctions(%) (Confidence Interval) | 99.92 (-0.1/+0.0) | 99.87 @ 20 mo. (-0.1/+0.1) | – | – | – | – | – | – | – | – | |||
| Malfunctions Only(%) (Confidence Interval) | 99.95 (-0.0/+0.0) | 99.92 @ 20 mo. (-0.1/+0.0) | – | – | – | – | – | – | – | – | ||||
| Effective Sample Size | 11471 | 879 | – | – | – | – | – | – | – | – | ||||
Subpectoral Implant 2009* Registered Implants: 24000 | Depletions and Malfunctions(%) (Confidence Interval) | 99.88 (-0.1/+0.0) | 99.77 (-0.1/+0.1) | 99.68 (-0.1/+0.1) | 99.68 @ 38 mo. (-0.1/+0.1) | – | – | – | – | – | – | |||
| Malfunctions Only(%) (Confidence Interval) | 99.89 (-0.1/+0.0) | 99.83 (-0.1/+0.0) | 99.82 @ 38 mo. (-0.1/+0.0) | 99.82 @ 38 mo. (-0.1/+0.0) | – | – | – | – | – | – | ||||
| Effective Sample Size | 26764 | 18459 | 2226 | 442 | – | – | – | – | – | – | ||||
