FDA Adverse Event
Malfunction
Summary report: N
OCTRODE
MDR report key: 2934291
·
Received January 7, 2013
Report
- Report Number
- 1627487-2013-04024
- Event Type
- Malfunction
- Date Received
- January 7, 2013
- Date of Event
- December 12, 2012
- Report Date
- December 12, 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: 1627487-2013-04025. IT WAS REPORTED THE PT WAS RECEIVING EFFECTIVE STIMULATION WHEN IN A SEATED POSITION, HOWEVER, WITH BODY MOVEMENT THE STIMULATION WAS EITHER TOO STRONG OR WOULD NOT BE FELT. THE SJM REPRESENTATIVE MET WITH THE PT AND REPROGRAMMING DID NOT RESOLVE THE ISSUE. IT WAS REPORTED THE PT WAS TO BE REFERRED TO ANOTHER PHYSICIAN FOR A SECOND OPINION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8643 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | R118466 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention | SCS IPG: MODEL 3788| IMPLANTED: |