FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2220674
·
Received August 23, 2011
Report
- Report Number
- 3006630150-2011-01308
- Event Type
- Injury
- Date Received
- August 23, 2011
- Date of Event
- July 28, 2011
- Report Date
- July 28, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#:SC-2218-50 SERIAL#:(B)(4), DESCRIPTION:ENH ST LD KIT,50 CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REVISION DUE TO DISCOMFORT. THE TENSION LOOPS OF THE LEADS WERE BULGING UP UNDER THE SKIN CAUSING DISCOMFORT. THE PHYSICIAN REVISED THE LEAD AND THE PATIENT IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Required Intervention |