FDA Adverse Event
Injury
Summary report: N
PENTA
MDR report key: 3890734
·
Received June 3, 2014
Report
- Report Number
- 1627487-2014-01379
- Event Type
- Injury
- Date Received
- June 3, 2014
- Date of Event
- May 10, 2014
- Report Date
- May 12, 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 INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
IT WAS REPORTED STIMULATION IS AUTO-REDUCING AND THE PT IS UNABLE INCREASE THE AMPLITUDE. IN ADDITION, STIMULATION IS NOT EFFECTIVE. DIAGNOSTIC TESTING REVEALED IMPEDANCES ARE WITHIN NORMAL RANGE. X-RAYS WERE ORDERED AS THE NEXT PLAN OF ACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 324405 | PENTA | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3228 | 4105746 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other | SCS IPG: MODEL 3788| IMPLANTED: |