FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1242989
·
Received November 21, 2008
Report
- Report Number
- 2029203-2008-01082
- Event Type
- Injury
- Date Received
- November 21, 2008
- Date of Event
- October 22, 2008
- Report Date
- October 22, 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
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS THE FINAL REPORT.
Description of Event or Problem · 1
A REPORT WAS RECEIVED STATING THAT A PATIENT WAS GOING TO HAVE A LEAD REVISION DUE TO LEAD MIGRATION. DURING THE PROCEDURE, THE PHYSICIAN DISCOVERED THAT IT WAS SCAR TISSUE PROTRUDING AND NOT A LEAD MIGRATION. THE PHYSICIAN PUSHED BACK THE SCAR TISSUE AND CLOSED THE PATIENT UP. NO REVISION WAS PERFORMED. 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-2138-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | LINEAR LEAD (PHASE IIIA) |