FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1250413
·
Received December 3, 2008
Report
- Report Number
- 2029203-2008-00997
- Event Type
- Injury
- Date Received
- December 3, 2008
- Date of Event
- November 6, 2008
- Report Date
- November 6, 2008
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICE WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A COMPLAINT WAS RECEIVED THAT A PATIENT'S PRECISION SYSTEM WAS EXPLANTED DUE TO INFECTION. THE PATIENT REPORTED SORENESS OVER THE POCKET SITE A MONTH AFTER IMPLANT, THEREFORE, THE PHYSICIAN DECIDED TO EXPLANT THE IPG. THE PATIENT IS REPORTEDLY DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1110 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention | ST LINEAR LEAD| MODEL# SC-2218-50 |