FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2172713
·
Received July 22, 2011
Report
- Report Number
- 3006630150-2011-01118
- Event Type
- Injury
- Date Received
- July 22, 2011
- Date of Event
- June 24, 2011
- Report Date
- June 24, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED IPG WILL NOT BE RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
THE PATIENT UNDERWENT A POCKET REVISION DUE TO DISCOMFORT AT THE CURRENT LOCATION. DURING THE REVISION THE PHYSICIAN REPLACED THE IPG, ALTHOUGH NO MALFUNCTION WAS SUSPECTED.
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 | 71 YR | Required Intervention |