FDA Adverse Event
Malfunction
Summary report: N
GENESIS
MDR report key: 2934301
·
Received January 7, 2013
Report
- Report Number
- 1627487-2013-02045
- Event Type
- Malfunction
- Date Received
- January 7, 2013
- Date of Event
- November 30, 2012
- Report Date
- December 14, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED THE PT'S IPG HAS BEEN AT STIMULATION OFF FOR THE PAST THREE WEEKS AND THE PROGRAMMER DISPLAYS A "BATTERY LOW" MESSAGE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8645 | GENESIS | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3643 | 3499159 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | SCS LEAD: MODEL 3156| IMPLANTED: |