FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2861107
·
Received December 4, 2012
Report
- Report Number
- 1627487-2012-12613
- Event Type
- Injury
- Date Received
- December 4, 2012
- Date of Event
- November 12, 2012
- Report Date
- November 12, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFORMATION 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
DEVICE 2 OF 2. REFERENCE MFR REPORT #1627487-2012-12612. IT WAS REPORTED, THE PT WAS IN A CAR ACCIDENT, AND WAS NO LONGER RECEIVING FULL STIMULATION COVERAGE. THE SJM REP INTERROGATED THE SYSTEM AND DETERMINED SEVERAL CONTACTS HAD INVALID IMPEDANCES. PT PLANS TO SEE IMPLANTING SURGEON WHEN HE IS RELEASED FROM THE FACILITY. NOTE THIS PT HAS TWO LEADS FROM DIFFERENT LOT NUMBERS. BOTH LEADS ARE BEING REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3700980 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Required Intervention | SCS IPG: MODEL 3788| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2) |