FDA Adverse Event
Malfunction
Summary report: N
PRECISION®
MDR report key: 2917100
·
Received January 15, 2013
Report
- Report Number
- 3006630150-2013-00059
- Event Type
- Malfunction
- Date Received
- January 15, 2013
- Date of Event
- December 17, 2012
- Report Date
- December 17, 2012
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8216-50, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD NO STIMULATION DUE TO LEAD MIGRATION. EXPLANT PROCEDURE WAS PERFORMED AND THE PATIENT WAS REPORTEDLY DOING FINE AFTER THE PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD NO STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT EXPLANT PROCEDURE WITH NO MALFUNCTION SUSPECTED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 22691 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-8216-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other |