FDA Adverse Event
Malfunction
Summary report: N
OCTRODE
MDR report key: 2801320
·
Received October 18, 2012
Report
- Report Number
- 1627487-2012-01882
- Event Type
- Malfunction
- Date Received
- October 18, 2012
- Date of Event
- September 26, 2012
- Report Date
- September 26, 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 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: 1627487-2012-1881. IT WAS REPORTED THE PT IS NO LONGER RECEIVING STIMULATION. AN SJM REPRESENTATIVE MET WITH THE PT AND LEAD DIAGNOSTIC SHOWED INVALID. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. X-RAYS WERE DONE AND DID NOT SHOW ANY ABNORMALITIES. SURGICAL INTERVENTION IS PENDING TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3108614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention | SCS ANCHOR: MODEL 1192| IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE: |