FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 2083304
·
Received May 10, 2011
Report
- Report Number
- 3006630150-2011-00647
- Event Type
- Injury
- Date Received
- May 10, 2011
- Date of Event
- April 17, 2011
- Report Date
- April 18, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED LEAD WAS NOT RETURNED TO BSN BECAUSE IT WAS DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT AFTER A LEAD REVISION SURGERY FOR INEFFECTIVE THERAPY THE PATIENT FELT NUMBNESS IN HER LEGS. THE PHYSICIAN BELIEVED THAT THE NEWLY IMPLANTED PADDLE LEAD WAS PUSHING ON A ROOT AND DECIDED TO EXPLANT THE LEAD. AFTER THE LEAD WAS EXPLANTED THE NUMBNESS WENT AWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-8216-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |