FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2052367
·
Received April 12, 2011
Report
- Report Number
- 3006630150-2011-00514
- Event Type
- Injury
- Date Received
- April 12, 2011
- Date of Event
- March 23, 2011
- Report Date
- March 23, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICES WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT HAD FALLEN AND WANTED A NEW IPG. THE PATIENT'S IPG HAD STOPPED TAKING CHARGE FOLLOWING THE FALL. THE PATIENT ALSO HAD SORENESS AROUND THE IPG SITE. THE FALL WAS NOT DEVICE RELATED. THE PATIENT UNDERWENT AN IPG REVISION AND IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |