FDA Adverse Event
Injury
Summary report: N
PENTA
MDR report key: 3949666
·
Received July 1, 2014
Report
- Report Number
- 1627487-2014-08090
- Event Type
- Injury
- Date Received
- July 1, 2014
- Date of Event
- June 10, 2014
- Report Date
- June 10, 2014
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, 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 ALLEGES HER SCS SYSTEM HAS NEVER WORKED TO RELIEVE HER PAIN. PATIENT WAS ADVISED TO CONTACT HER PHYSICIAN TO DETERMINE NEXT STEPS IN ADDRESSING THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 381701 | PENTA | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3228 | 3741496 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other | SCS IPG: MODEL 3788| IMPLANT: |