FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1833421
·
Received September 9, 2010
Report
- Report Number
- 3006630150-2010-01503
- Event Type
- Injury
- Date Received
- September 9, 2010
- Date of Event
- August 12, 2010
- Report Date
- August 12, 2010
- 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
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT'S IPG HAD ERODED THROUGH THE SKIN DUE TO AN INFECTION AT THE POCKET SITE. THE IPG WAS EXPLANTED AND THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS; A NEW IPG WILL BE IMPLANTED AFTER THE PATIENT HAS HEALED. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention |