FDA Adverse Event
Injury
Summary report: N
PRECISION SPECTRA®
MDR report key: 3942457
·
Received July 17, 2014
Report
- Report Number
- 3006630150-2014-01646
- Event Type
- Injury
- Date Received
- July 17, 2014
- Date of Event
- June 27, 2014
- Report Date
- June 27, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT¿S INCISION SITE WAS NOT HEALING. IT WAS BELIEVED TO BE NOT DEVICE OR PROCEDURE RELATED. NO INFECTION WAS SUSPECTED. THE PATIENT WAS PRESCRIBED SULFA AS PROPHYLAXIS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS RELOCATED ALONG WITH DEBRIDEMENT OF INCISION. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 418013 | PRECISION SPECTRA® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |