FDA Adverse Event
Other
Summary report: N
GENESIS
MDR report key: 2992748
·
Received March 4, 2013
Report
- Report Number
- 1627487-2013-03316
- Event Type
- Other
- Date Received
- March 4, 2013
- Date of Event
- February 6, 2013
- Report Date
- February 6, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUOMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED A "LOW BATTERY" MESSAGE ON THE PATIENT PROGRAMMER. A SJM REPRESENTATIVE WAS ABLE TO CLEAR THE MESSAGE; HOWEVER, PER THE PATIENT, THE MESSAGE REAPPEARED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 90613 | GENESIS | SCS IPG | LGW | ST. JUDE MEDICAL - NEUOMODULATION | 3643 | 2804705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |