FDA Adverse Event
Malfunction
Summary report: N
PRECISION
MDR report key: 1030502
·
Received April 17, 2008
Report
- Report Number
- 2029203-2008-00245
- Event Type
- Malfunction
- Date Received
- April 17, 2008
- Date of Event
- March 20, 2008
- Report Date
- March 21, 2008
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORP
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- 2029203-10/17/08-001-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THIS IS A FINAL REPORT.
Description of Event or Problem · 1
AN ATTEMPT TO UPGRADE THE FIRMWARE WAS UNSUCCESSFUL AND STIMULATION WAS LOST. THE PT WAS HOSPITALIZED FOR PAIN DUE TO LOSS OF STIMULATION. THE PT WAS REPROGRAMMED AT A LATER DATE AND IS RECEIVING ADEQUATE THERAPY FROM THE SYSTEM. THE FIRMWARE UPGRADE PROCESS WAS ALSO REPEATED WITH ACCEPTABLE OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORP | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |