FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3232744
·
Received July 18, 2013
Report
- Report Number
- 3006630150-2013-01496
- Event Type
- Injury
- Date Received
- July 18, 2013
- Date of Event
- June 27, 2013
- Report Date
- June 27, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8216-70, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT¿S INCISION SITE WAS OOZING WITH PUS COMING OUT THE IPG SITE AND STARTED SPLITTING OPEN. THE PHYSICIAN GAVE THE PATIENT ANTIBIOTICS. THE PATIENT HAD INFECTION WHICH WAS BELIEVED TO BE PROCEDURE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335925 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |