FDA Adverse Event
Malfunction
Summary report: N
PRECISION®
MDR report key: 2921302
·
Received January 17, 2013
Report
- Report Number
- 3006630150-2013-00084
- Event Type
- Malfunction
- Date Received
- January 17, 2013
- Date of Event
- December 28, 2012
- Report Date
- December 28, 2012
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING THE IPG. THE PHYSICIAN ELECTED TO REPLACE THE IPG. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING THE IPG. THE PHYSICIAN ELECTED TO REPLACE THE IPG. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27034 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |