|
U.S. Registered Implants:
66,000 U.S. Approval Date: May 2008 U.S. Estimated Active Implants: 55,000 | U.S. Normal Battery Depletions:
32 U.S. Unconfirmed Reports of Premature Battery Depletion: 9 U.S. Malfunctions:92 Without Compromised Therapy:53 With Compromised Therapy:39 |
 |
 |
 |
| Year | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Non Advisory Population Registered Implants: 34000 | Depletions and Malfunctions(%) (Confidence Interval) | 99.93 (-0.0/+0.0) | 99.90 @ 21 mo. (-0.1/+0.0) | – | – | – | – | – | – | – | – | |||
| Malfunctions Only(%) (Confidence Interval) | 99.96 (-0.0/+0.0) | 99.94 @ 21 mo. (-0.1/+0.0) | – | – | – | – | – | – | – | – | ||||
| Effective Sample Size | 12588 | 213 | – | – | – | – | – | – | – | – | ||||
| Advisory: 01-Dec-09 (Subpectoral Implant 2009)* Registered Implants: 50000 | Depletions and Malfunctions(%) (Confidence Interval) | 99.79 (-0.1/+0.0) | 99.66 (-0.1/+0.1) | 99.41 (-0.2/+0.2) | 99.41 @ 38 mo. (-0.2/+0.2) | – | – | – | – | – | – | – | ||
| Malfunctions Only(%) (Confidence Interval) | 99.81 (-0.1/+0.0) | 99.74 (-0.1/+0.1) | 99.67 (-0.1/+0.1) | 99.67 @ 38 (-0.1/+0.1) | – | – | – | – | – | – | ||||
| Effective Sample Size | 27572 | 18881 | 2251 | 470 | – | – | – | – | – | – | ||||
