FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1940870
·
Received December 23, 2010
Report
- Report Number
- 3006630150-2010-02208
- Event Type
- Injury
- Date Received
- December 23, 2010
- Date of Event
- December 7, 2010
- Report Date
- December 7, 2010
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PT UNDERWENT A POCKET REVISION DUE TO DISCOMFORT AT THE POCKET SITE. THE PHYSICIAN RELOCATED THE IPG TO A MORE COMFORTABLE POSITION AND THE PT WAS REPORTEDLY DOING WELL FOLLOWING 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 | UNK | Required Intervention |