FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2940596
·
Received January 29, 2013
Report
- Report Number
- 1627487-2013-12135
- Event Type
- Injury
- Date Received
- January 29, 2013
- Date of Event
- January 4, 2013
- Report Date
- January 4, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT FOR INEFFECTIVE STIMULATION WAS CONFIRMED. AS RECEIVED, ONE OF THE TWO LEADS RECEIVED HAD A BENT AREA WITH ALL CONDUCTING WIRES BROKEN. THE OTHER LEAD WAS IN GOOD CONDITION AND PASSED FUNCTIONAL TESTING. 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 2 OF 2. REFERENCE MFR REPORT #1627487-2013-12134.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 38833 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 2751892 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention | SCS IPG: MODEL 3788| IMPLANT: |