FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1885168
·
Received October 25, 2010
Report
- Report Number
- 3006630150-2010-01824
- Event Type
- Injury
- Date Received
- October 25, 2010
- Date of Event
- September 27, 2010
- Report Date
- September 27, 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A REPORT WAS REC'D THAT THE PT WAS IN PAIN AND WAS PRESCRIBED MEDICATION BY THE PHYSICIAN. THE PT IS REPORTEDLY DOING FINE.
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 | UNK | Required Intervention |