FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2874481
·
Received December 14, 2012
Report
- Report Number
- 3006630150-2012-02391
- Event Type
- Injury
- Date Received
- December 14, 2012
- Date of Event
- September 12, 2012
- Report Date
- September 12, 2012
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION AND WAS DOING WELL POST-OPERATIVELY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A POCKET REVISION DUE TO PAIN AT THE POCKET SITE AND INABILITY TO CHARGE THE IPG.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A POCKET REVISION DUE TO PAIN AT THE POCKET SITE AND INABILITY TO CHARGE THE IPG.
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 | Required Intervention |