FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1001056
·
Received February 22, 2008
Report
- Report Number
- 2029203-2008-00071
- Event Type
- Injury
- Date Received
- February 22, 2008
- Date of Event
- January 25, 2008
- Report Date
- January 25, 2008
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE IPG REMAINS IMPLANTED IN THE PATIENT AND WILL NOT BE RETURNED FOR EVALUATION. THE PATIENT IS REPORTEDLY DOING WELL. THIS IS THE FINAL REPORT.
Description of Event or Problem · 1
THE PATIENT REPORTED PAIN AT THE IMPLANT SITE. THE SURGEON TREATED THE PAIN WITH STEROID INJECTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |