FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1071641
·
Received July 9, 2008
Report
- Report Number
- 2029203-2008-00493
- Event Type
- Injury
- Date Received
- July 9, 2008
- Date of Event
- March 8, 2008
- Report Date
- June 9, 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
- US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS IS THE FINAL REPORT.
Description of Event or Problem · 1
SHORTLY AFTER AN IMPLANT PROCEDURE, THE PATIENT REPORTED THAT SHE FELL AND SPLIT HER POCKET SITE OPEN. THE PATIENT WAS RESTITCHED AND TREATED WITH ANTIBIOTICS. THE PATIENT IS REPORTEDLY DOING WELL.
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 | Hospitalization| R |