FDA Adverse Event
Malfunction
Summary report: N
PRECISION®
MDR report key: 3981814
·
Received August 5, 2014
Report
- Report Number
- 3006630150-2014-01776
- Event Type
- Malfunction
- Date Received
- August 5, 2014
- Date of Event
- July 14, 2014
- Report Date
- July 14, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL, PERFORMANCE AND PHOTOGRAPHIC IMAGING TESTS PERFORMED. THE COMPLAINT OF DIFFICULTY CHARGING WAS NOT CONFIRMED. BATTERY PROFILE REVEALED A DEPLETION RATE OF 9MV PER DAY, WITH STIMULATION SWITCHED OFF, WHICH IS WITHIN THE EXPECTED RANGE. DEVICE EXHIBITS NORMAL CHARGING AND DISCHARGING CHARACTERISTICS.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING AS THE IPG WOULD NO LONGER CHARGE. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND DID WELL POSTOPERATIVELY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING AS THE IPG WOULD NO LONGER CHARGE. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND DID WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 458128 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |