FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2160715
·
Received July 13, 2011
Report
- Report Number
- 3006630150-2011-01078
- Event Type
- Injury
- Date Received
- July 13, 2011
- Date of Event
- June 13, 2011
- Report Date
- June 13, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD GAINED WEIGHT AND WHEN SITTING IN HER WHEELCHAIR THE CHAIR WOULD PUSH ON THE IPG. THE IPG WAS REPOSITIONED IN THE POCKET AND THE PATIENT WAS REPORTEDLY DOING FINE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO A REVISION DUE TO THE IPG BEING TILTED IN THE POCKET.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WOULD UNDERGO A REVISION DUE TO THE IPG BEING TILTED IN THE POCKET.
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 | 53 YR | Required Intervention |