FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3163607
·
Received June 11, 2013
Report
- Report Number
- 3006630150-2013-01207
- Event Type
- Injury
- Date Received
- June 11, 2013
- Date of Event
- May 20, 2013
- Report Date
- May 20, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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 WAS EXPERIENCING DISCOMFORT AT THE POCKET SITE. THE PATIENT UNDERWENT A POCKET REVISION, DURING WHICH, THE LEADS AND IPG WERE REPLACED PER PHYSICIAN'S PREFERENCE. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 264136 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |