FDA Adverse Event
Malfunction
Summary report: N
OCTRODE
MDR report key: 2934664
·
Received January 4, 2013
Report
- Report Number
- 1627487-2013-05055
- Event Type
- Malfunction
- Date Received
- January 4, 2013
- Date of Event
- December 11, 2012
- Report Date
- December 11, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- 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
THE PT HAS TWO LEADS (FROM THE SAME LOT). IT WAS REPORTED THE PT IS NOT RECEIVING ADEQUATE COVERAGE. THE PT WAS REPROGRAMMED AND WILL USE THE NEW SETTINGS TO SEE IF SHE RECEIVE PAIN RELIEF OVER TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5641 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 (X2) | 3599429 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention | SCS ANCHORS: MODEL 1192 (X2)| SCS IPG: MODEL 3788| IMPLANT:| IMPLANT: |