FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1930967
·
Received December 14, 2010
Report
- Report Number
- 3006630150-2010-02127
- Event Type
- Injury
- Date Received
- December 14, 2010
- Date of Event
- November 23, 2010
- Report Date
- November 23, 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
- IA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT FOLLOWING AN IMPLANT PROCEDURE, THE PT WAS FEELING NUMBNESS IN HIS LEGS. THE PHYSICIAN BELIEVED THAT THERE WAS EITHER A BLOOD CLOT OR THAT THE LEAD WAS PUTTING PRESSURE ON THE SPINAL CORD. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM AND THE PT WAS ABLE TO REGAIN FEELING IN HIS LEGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-8216-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | (B)(4)| MODEL #: SC-1110-02| IPG KIT WITHOUT PULL-THROUGH TUNNELER: |