FDA Adverse Event
Injury
Summary report: N
PENTA
MDR report key: 4060291
·
Received August 25, 2014
Report
- Report Number
- 1627487-2014-08218
- Event Type
- Injury
- Date Received
- August 25, 2014
- Date of Event
- August 10, 2011
- Report Date
- August 7, 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 HAS REQUESTED AN EXPLANT DUE TO THE SCS SYSTEM ALLEGEDLY NEVER HELPING HER PAIN. SURGICAL INTERVENTION IS PLANNED FOR A LATER DATE TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 513466 | PENTA | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3228 | 4319393 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other | IMPLANT DATE:| SCS ANCHOR, MODEL: 1194 (X2)| IMPLANT DATE:| SCS IPG, MODEL: 3788 |