PRECISION®
Report
- Report Number
- 3006630150-2013-00789
- Event Type
- Malfunction
- Date Received
- April 23, 2013
- Date of Event
- March 12, 2013
- Report Date
- March 22, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT WAS NOT VERIFIED. UPON RECEIVING, THE IPG WAS IN HIBERNATION. IN THE LAB, THE IPG WAS CHARGED IN TWO CHARGING CYCLES. THE CHARGE PROFILE REVEALED NO ANOMALIES. BATTERY DEPLETION RATE AND SLEEP CURRENT RATE OF THE DEVICE WERE WITHIN THE EXPECTED RANGES. THE DEVICE PASSED ALL REQUIRED TESTS. THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN IPG REPLACEMENT. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.
A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG WAS UNRESPONSIVE. THE IPG WOULD NOT CONNECT TO THE REMOTE CONTROL (RC), IT WOULD NOT CHARGE AND THE RC WAS SHOWING ERROR CODE 8000. THE PATIENT WILL UNDERGO A POCKET REVISION.
A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS UNRESPONSIVE. THE IPG WOULD NOT CONNECT TO THE REMOTE CONTROL (RC), IT WOULD NOT CHARGE AND THE RC WAS SHOWING ERROR CODE 8000. THE PATIENT WILL UNDERGO A POCKET REVISION.
A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG WAS UNRESPONSIVE. THE IPG WOULD NOT CONNECT TO THE REMOTE CONTROL (RC), IT WOULD NOT CHARGE AND THE RC WAS SHOWING ERROR CODE 8000. THE PATIENT WILL UNDERGO A POCKET REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 174687 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |