FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 2233300
·
Received September 2, 2011
Report
- Report Number
- 3006630150-2011-01395
- Event Type
- Injury
- Date Received
- September 2, 2011
- Date of Event
- August 3, 2011
- Report Date
- August 3, 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
IT WAS REPORTED THAT PATIENT GOT A POCKET REVISION DUE TO POCKET DISCOMFORT FROM THE IPG BEING TOO SHALLOW. PATIENT IS DOING FINE AND NOTHING WAS IMPLANTED OR EXPLANTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT GOT A POCKET REVISION DUE TO POCKET DISCOMFORT FROM THE IPG BEING TOO SHALLOW. PATIENT IS DOING FINE AND NOTHING WAS IMPLANTED OR EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |