FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2844553
·
Received November 16, 2012
Report
- Report Number
- 1627487-2012-14047
- Event Type
- Injury
- Date Received
- November 16, 2012
- Date of Event
- October 23, 2012
- Report Date
- October 23, 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 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
DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-14048. IT WAS REPORTED, THE PT WAS NO LONGER RECEIVING EFFECTIVE STIMULATION IN HIS RIGHT LEG AND LOW BACK. AN SJM REP MET WITH THE PT AND REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. X-RAYS WERE TAKEN AND SHOWED THE LEAD HAD MIGRATED. THE PT UNDERWENT REVISION SURGERY ON (B)(6) 2012 WHERE THE PHYSICIAN REPOSITIONED THE LEAD. THE PT IS NOW RECEIVING EFFECTIVE STIMULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3769670 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | SCS IPG: MODEL 3788| IMPLANT:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT: |