FDA Adverse Event
Injury
Summary report: N
PENTA
MDR report key: 3851341
·
Received May 22, 2014
Report
- Report Number
- 1627487-2014-25400
- Event Type
- Injury
- Date Received
- May 22, 2014
- Date of Event
- May 2, 2014
- Report Date
- May 2, 2014
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- 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
IT WAS REPORTED THE PATIENT IS NOT RECEIVING STIMULATION. X-RAYS IDENTIFIED LEAD MIGRATION. THE PATIENT UNDERWENT A TRIAL PROCEDURE ON (B)(6) 2014 TO ADDRESS THE ISSUE. FOLLOW-UP REVEALED THE PATIENT'S TRIAL WAS SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306160 | PENTA | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3228 | 3710188 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other | SCS IPG, MODEL: 3788| IMPLANT DATE: |