FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1933764
·
Received December 16, 2010
Report
- Report Number
- 3006630150-2010-02160
- Event Type
- Injury
- Date Received
- December 16, 2010
- Date of Event
- November 30, 2010
- Report Date
- December 1, 2010
- Manufacturer
- BOSTON SCIENTIFIC NEURMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A PT'S IPG WAS EXPLANTED DUE TO DISCOMFORT. THE PT HAD LOST WEIGHT (NOT DEVICE RELATED) AND THE IPG WAS NOT SITTING RIGHT; CAUSING DISCOMFORT. THE PHYSICIAN CHOSE TO EXPLANT THE IPG BECAUSE THE PT'S PAIN PATTERN HAD CHANGED. THE PT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEURMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention |