FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2902359
·
Received January 8, 2013
Report
- Report Number
- 3006630150-2012-02492
- Event Type
- Injury
- Date Received
- January 8, 2013
- Date of Event
- December 17, 2012
- Report Date
- December 17, 2012
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50 SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE DUE TO DISCOMFORT AT THE LEAD SITE. DURING THE PROCEDURE, THE PHYSICIAN MOVED THE ANCHORS TO A MORE COMFORTABLE SPOT. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8997 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-4316 | 14983493 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |