FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1953491
·
Received January 5, 2011
Report
- Report Number
- 3006630150-2010-02249
- Event Type
- Injury
- Date Received
- January 5, 2011
- Date of Event
- December 14, 2010
- Report Date
- December 14, 2010
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PT WOULD BE EXPLANTED. NO FURTHER DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention | ST LINEAR LEAD, 70CM WITH PRE-LOADED 0.012" STYLET| MODEL #: SC-2208-70, (B)(4)| (B)(4) |