FDA Adverse Event
Injury
Summary report: N
GENESIS PULSE GENERATOR, 8-CHANNEL
MDR report key: 2100778
·
Received May 19, 2011
Report
- Report Number
- 1627487-2011-00690
- Event Type
- Injury
- Date Received
- May 19, 2011
- Date of Event
- April 22, 2011
- Report Date
- April 22, 2011
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- 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 WAS IMPLANTED WITH AN IPG ON (B)(6) 2008. IT WAS REPORTED THAT HIS IPG WAS REPLACED BECAUSE THE DEVICE HAD REACHED ITS END-OF LIFE. EFFECTIVE STIMULATION WAS RECAPTURED AS A RESULT OF THE PROCEDURE AND NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENESIS PULSE GENERATOR, 8-CHANNEL | TOTALLY IMPLANTABLE PULSE GENERATOR | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3608 | R118227 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | IMPLANT DATE:| MODEL: 3245 |