FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2112074
·
Received June 2, 2011
Report
- Report Number
- 3006630150-2011-00820
- Event Type
- Injury
- Date Received
- June 2, 2011
- Date of Event
- May 12, 2011
- Report Date
- May 12, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED IPG PASSED VISUAL, ELECTRICAL AND PERFORMANCE TESTS DONE. THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS EXPLANTED DUE TO DISCOMFORT. THE PATIENT IS DOING WELL FOLLOWING THE REVISION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS EXPLANTED DUE TO DISCOMFORT. 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 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention |