FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2151842
·
Received July 6, 2011
Report
- Report Number
- 3006630150-2011-01017
- Event Type
- Injury
- Date Received
- July 6, 2011
- Date of Event
- June 10, 2011
- Report Date
- June 10, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT'S IPG MOVED AND THE PATIENT IS EXPERIENCING A BURNING SENSATION AT THE POCKET SITE. THE PATIENT UNDERWENT A POCKET REVISION TO MAKE THE IPG DEEPER. THE PATIENT IS DOING WELL FOLLOWING THE REVISION.
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 | 45 YR | Required Intervention |