FDA Adverse Event
Malfunction
Summary report: N
OCTRODE
MDR report key: 2913553
·
Received December 21, 2012
Report
- Report Number
- 1627487-2012-14262
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- November 27, 2012
- Report Date
- December 3, 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
DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-14261. IT WAS REPORTED THE PATIENT IS NO LONGER RECEIVING EFFECTIVE STIMULATION IN HIS RIGHT LEG AFTER EXPERIENCING A JOLTING EPISODE. AN SJM REPRESENTATIVE MET WITH THE PATIENT AND LEAD DIAGNOSTICS SHOWED ONE INVALID CONTACT. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. X-RAYS HAVE BEEN ORDERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3399964 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention | SCS IPG: MODEL 3788| SCS ANCHOR, MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE: |