FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1400716
·
Received June 11, 2009
Report
- Report Number
- 2029203-2009-00801
- Event Type
- Injury
- Date Received
- June 11, 2009
- Date of Event
- January 31, 2007
- Report Date
- January 31, 2007
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
DEVICE REMAINS IN PATIENT. THIS IS A FINAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POCKET REVISION DUE TO LOSS OF STIMULATION IN THE APPROPRIATE AREA AND UNPLEASANT STIMULATION IN THE LOWER LEFT RIB. THE IPG HAD TURNED AND WAS REPOSITONED. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE REVISON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |