FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1990810
·
Received February 8, 2011
Report
- Report Number
- 3006630150-2011-00191
- Event Type
- Injury
- Date Received
- February 8, 2011
- Date of Event
- January 14, 2011
- Report Date
- January 14, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION TO REPOSITION THE IPG TO A MORE COMFORTABLE AREA. THE IPG WAS MOVED MORE ANTERIOR. THE PATIENT WAS DOING FINE AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |