FDA Adverse Event
Malfunction
Summary report: N
GENESIS DUAL XP RECHARGEABLE IPG
MDR report key: 2201456
·
Received August 4, 2011
Report
- Report Number
- 1627487-2011-07019
- Event Type
- Malfunction
- Date Received
- August 4, 2011
- Date of Event
- July 8, 2011
- Report Date
- July 8, 2011
- Manufacturer
- ST JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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
THE PT RECEIVED A SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED ON (B)(6) 2011 THAT PT PROGRAMMER WON'T COMMUNICATE AND ERROR CODE 2500 WAS OBSERVED. THE PT DOES NOT HAVE STIMULATION AND THE IPG IS SHALLOW. NO FURTHER INFO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENESIS DUAL XP RECHARGEABLE IPG | TOTALLY IMPLANTABLE PULSE GENERATOR | LGW | ST JUDE MEDICAL - NEUROMODULATION | 3644 | 114161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |