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U.S. Registered Implants:
33,000 U.S. Approval Date: May 2008 U.S. Estimated Active Implants: 29,000 | U.S. Normal Battery Depletions:
18 U.S. Unconfirmed Reports of Premature Battery Depletion: 0 U.S. Malfunctions:46 Without Compromised Therapy:15 With Compromised Therapy:31 |
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| Year | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Non Advisory Population Registered Implants: 17000 | Depletions and Malfunctions(%) (Confidence Interval) | 99.88 (-0.1/+0.1) | 99.85 @ 20 mo. (-0.1/+0.1) | – | – | – | – | – | – | – | – | |||
| Malfunctions Only(%) (Confidence Interval) | 99.91 (-0.1/+0.0) | 99.91 @ 20 mo. (-0.1/+0.0) | – | – | – | – | – | – | – | – | ||||
| Effective Sample Size | 5706 | 466 | – | – | – | – | – | – | – | – | ||||
Subpectoral Implant 2009* Registered Implants: 24000 | Depletions and Malfunctions(%) (Confidence Interval) | 99.77 (-0.1/+0.1) | 99.56 (-0.1/+0.1) | 99.57 (-0.1/+0.1) | 99.57 @ 38 (-0.1/+0.1) | – | – | – | – | – | – | |||
| Malfunctions Only(%) (Confidence Interval) | 99.80 (-0.1/+0.1) | 99.74 (-0.1/+0.1) | 99.72 (-0.1/+0.1) | 99.72 @ 38 (-0.1/+0.1) | – | – | – | – | – | – | ||||
| Effective Sample Size | 13688 | 9476 | 1191 | NaN | – | – | – | – | – | – | ||||
