FDA Adverse Event
Injury
Summary report: N
SC-1110-02
MDR report key: 2653865
·
Received July 12, 2012
Report
- Report Number
- 3006630150-2012-01268
- Event Type
- Injury
- Date Received
- July 12, 2012
- Date of Event
- June 18, 2012
- Report Date
- June 18, 2012
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION DUE TO DISCOMFORT. THE PHYSICIAN REPOSITIONED THE IPG FROM THE LEFT SIDE TO THE RIGHT SIDE. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SC-1110-02 | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |