FDA Adverse Event
Injury
Summary report: N
PRECISION SPECTRA®
MDR report key: 3923765
·
Received July 9, 2014
Report
- Report Number
- 3006630150-2014-01540
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- June 13, 2014
- Report Date
- June 13, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT FELT THE IPG SITE WAS GETTING HOT. IT WAS NOTED THAT THE IPG WAS PROTRUDING MORE AND THE SKIN WAS SHOWING REDNESS. THE PHYSICIAN ADMINISTERED AN ANTIBIOTIC SHOT FOR PRECAUTION AND BELIEVED THAT THERE WAS NO INFECTION. THE PATIENT WAS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401522 | PRECISION SPECTRA® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |