FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1936032
·
Received December 13, 2010
Report
- Report Number
- 3006630150-2010-02088
- Event Type
- Injury
- Date Received
- December 13, 2010
- Date of Event
- November 22, 2010
- Report Date
- November 22, 2010
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PT IS EXPERIENCING DISCOMFORT AT THE IPG SITE. DURING THE POCKET REVISION THE PHYSICIAN PULLED ON THE PADDLE LEAD WHICH CAUSED IT TO FRAY. THE PT WAS SENT TO ANOTHER PHYSICIAN TO UNDERGO A DEVICE REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention | (B)(6)| ARTISAN SURGICAL LD 50CM: MODEL# SC-8120-50| ARTISAN SURGICAL LD 50CM: MODEL# SC-8120-50| (B)(4) |