FDA Adverse Event
Injury
Summary report: N
EON
MDR report key: 3031926
·
Received March 28, 2013
Report
- Report Number
- 1627487-2013-06112
- Event Type
- Injury
- Date Received
- March 28, 2013
- Date of Event
- March 6, 2013
- Report Date
- March 6, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- 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'S IPG WAS NO LONGER HOLDING A CHARGE AND IT DEPLETED. FOLLOW UP INDICATES THE PATIENT WAS IMPLANTED WITH A NEW IPG ON (B)(6) 2013 AND EFFECTIVE STIMULATION WAS RECAPTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 127749 | EON | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3716 | 63496 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | IMPLANT DATE:| SCS LEAD: MODEL CD393 |