PRECISION®
Report
- Report Number
- 3006630150-2012-02418
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- December 7, 2012
- Report Date
- December 7, 2012
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND DID WELL POSTOPERATIVELY. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-1110 SERIAL/LOT #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG) MODEL #: SC-2138-70, SERIAL/LOT #: (B)(4), DESCRIPTION: SCS 70CM III LEAD MODEL #: SC-2138-50, SERIAL/LOT #: (B)(4), DESCRIPTION: SCS 50CM III LEAD MODEL #: SC-3138-25, SERIAL/LOT #: (B)(4), DESCRIPTION: SCS PHIII EXT 25CM THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES 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.
A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE DUE TO INABILITY TO CHARGE.
A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE DUE TO INABILITY TO CHARGE.
A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE DUE TO INABILITY TO CHARGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |