PRECISION®
Report
- Report Number
- 3006630150-2011-01138
- Event Type
- Injury
- Date Received
- August 4, 2011
- Date of Event
- June 29, 2011
- Report Date
- June 29, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE ANALYSIS CONFIRMED THE COMPLAINT. THE IPG PASSED ALL THE FUNCTIONAL TESTS, HOWEVER IT EXHIBITED EXCESSIVE BATTERY DEPLETION DUE TO HIGH CURRENT LEAKAGE. THE DEVICE CHARACTERISTICS SEEMS TO HAVE CHANGED JUST PRIOR TO THE IMPLANT. THE SOURCE OF LEAKAGE WAS FOUND TO BE EITHER ANALOG OR DIGITAL IC. TROUBLESHOOTING TO SPECIFIC COMPONENT LEVEL IS IMPOSSIBLE SINCE BOTH ANALOG/DIGITAL ICS ARE COVERED IN THE EPOXY RESIN TOP.
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAS DECIDED TO PROCEED WITH AN IPG REVISION.
A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING. A BSN ENGINEER CONFIRMED THAT THE IPG EXHIBITS PREMATURE BATTERY DEPLETION.
A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING. A BSN ENGINEER CONFIRMED THAT THE IPG EXHIBITS PREMATURE BATTERY DEPLETION.
A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING. A BSN ENGINEER CONFIRMED THAT THE IPG EXHIBITS PREMATURE BATTERY DEPLETION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |