FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2870372
·
Received December 12, 2012
Report
- Report Number
- 3006630150-2012-02300
- Event Type
- Injury
- Date Received
- December 12, 2012
- Date of Event
- November 21, 2012
- Report Date
- November 21, 2012
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2352-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR 3-4 LEAD, 50CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO DISCOMFORT AT THE LEAD SITE. THE PHYSICIAN RELOCATED THE IPG AND EXTENSIONS WERE IMPLANTED. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2352-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |