FDA Adverse Event
Malfunction
Summary report: N
GENESIS 8-CHANNEL RECHARGEABLE IPG
MDR report key: 2181432
·
Received July 6, 2011
Report
- Report Number
- 1627487-2011-03204
- Event Type
- Malfunction
- Date Received
- July 6, 2011
- Date of Event
- January 25, 2011
- Report Date
- June 7, 2011
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- 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
THE PATIENT RECEIVED A SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE STIMULATION. THE SJM REPRESENTATIVE TRIED ALTERNATE PROGRAMMERS TO RESOLVE THE ISSUE BUT TO NO AVAIL. THE PATIENT IS WORKING WITH HIS PHYSICIAN TO DETERMINE NEXT COURSE OF ACTION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENESIS 8-CHANNEL RECHARGEABLE IPG | TOTALLY IMPLANTABLE PULSE GENERATOR | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3608 | 118590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |