PRECISION®
Report
- Report Number
- 3006630150-2013-00197
- Event Type
- Malfunction
- Date Received
- February 6, 2013
- Date of Event
- January 15, 2013
- Report Date
- January 15, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.
(B)(4): ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WILL BE NO FURTHER COURSE OF ACTION DUE TO NON-DEVICE RELATED MEDICAL ISSUES.
(B)(4).
A REPORT WAS RECEIVED THAT DURING AN IPG REPLACEMENT (REPORTED IN MFR REPORT #: 3006630150-2012-02434), THE LEAD WAS DAMAGED. THE PHYSICIAN ELECTED TO LEAVE THE DAMAGED LEAD INSIDE THE PATIENT'S BODY.
A REPORT WAS RECEIVED THAT THE ARTISAN LEAD WAS DAMAGED DURING THE IPG REPLACEMENT.
A REPORT WAS RECEIVED THAT DURING AN IPG REPLACEMENT (REPORTED IN MFR REPORT #: 3006630150-2012-02434), THE LEAD WAS DAMAGED. THE PHYSICIAN ELECTED TO LEAVE THE DAMAGED LEAD INSIDE THE PATIENT'S BODY.
A REPORT WAS RECEIVED THAT DURING AN IPG REPLACEMENT (REPORTED IN MFR REPORT #: 3006630150-2012-02434), THE LEAD WAS DAMAGED. THE PHYSICIAN ELECTED TO LEAVE THE DAMAGED LEAD INSIDE THE PATIENT'S BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 50744 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-8116-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |