FDA Adverse Event
Injury
Summary report: N
PENTA
MDR report key: 3950204
·
Received June 27, 2014
Report
- Report Number
- 1627487-2014-26534
- Event Type
- Injury
- Date Received
- June 27, 2014
- Report Date
- June 6, 2014
- Manufacturer
- ST. JUDE MEDICAL - NEURMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 REPORTED, SHE HAD A LEAD REVISION FOR UNWANTED ABDOMINAL STIMULATION ON AN UNKNOWN DATE AND ST. JUDE MEDICAL WAS NOT NOTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 376684 | PENTA | SCS LEAD | GZB | ST. JUDE MEDICAL - NEURMODULATION | 3228 | 3333073 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | SCS IPG: MODEL 3788| IMPLANT DATE: |