FDA Adverse Event
Malfunction
Summary report: N
OCTRODE
MDR report key: 2971487
·
Received February 4, 2013
Report
- Report Number
- 1627487-2013-05168
- Event Type
- Malfunction
- Date Received
- February 4, 2013
- Date of Event
- January 14, 2013
- Report Date
- January 14, 2013
- 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
THE PT HAS TWO LEADS (FROM THE SAME LOT). IT WAS REPORTED THE PT IS NO LONGER RECEIVING ADEQUATE COVERAGE. THE PT MAY UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47344 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 (X2) | 3333114 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | SCS ANCHORS: MODEL: 1192 (X2)| IMPLANT:| SCS IPG: MODEL: 3788| IMPLANT: |