FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2993562
·
Received March 7, 2013
Report
- Report Number
- 3006630150-2013-00391
- Event Type
- Injury
- Date Received
- March 7, 2013
- Date of Event
- February 12, 2013
- Report Date
- February 12, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION DUE TO DISCOMFORT AT THE BATTERY SITE. DURING THE PROCEDURE, THE PHYSICIAN JUST RELOCATED THE IPG. THE PATIENT IS DOING WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98227 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |