FDA Adverse Event
Malfunction
Summary report: N
PRECISION
MDR report key: 1820089
·
Received August 24, 2010
Report
- Report Number
- 3006630150-2010-01509
- Event Type
- Malfunction
- Date Received
- August 24, 2010
- Date of Event
- July 8, 2010
- Report Date
- July 8, 2010
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG DOCUMENTATION OF THE EXPLANTED DEVICES FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MFG. THIS IS THE FINAL REPORT.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PT WAS EXPERIENCING CHARGING DIFFICULTY. PREMATURE BATTERY DEPLETION WAS CONFIRMED BY A BSN ENGINEER, AND IPG REPLACEMENT WAS RECOMMENDED. THE PHYSICIAN HAS OPTED NOT TO PERFORM THE REPLACEMENT AS THE PT WILL UNDERGO A NON-DEVICE RELATED SURGERY. THE BSN SALES REP REPORTED THAT THE PT IS STILL USING THE DEVICE ALTHOUGH IT IS DEPLETING QUICKER THAN NORMAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |