FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2980049
·
Received February 22, 2013
Report
- Report Number
- 1627487-2013-13353
- Event Type
- Injury
- Date Received
- February 22, 2013
- Date of Event
- January 30, 2013
- Report Date
- January 30, 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
SJM HAS LIMITED INFO 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 NUMBER. IT WAS REPORTED THE PT WASN'T RECEIVING STIMULATION COVERAGE ON HER LEFT SIDE. A SJM REP RAN A LEAD DIAGNOSTIC TEST AND THE 2 ACTIVE CONTACTS HAD LOW IMPEDANCES. REPROGRAMMING WITH THE EXISTING CONTACTS WAS ABLE TO CAPTURE SOME STIMULATION, HOWEVER, IT WAS NOT AS GOOD AS THE PT'S RIGHT SIDE COVERAGE. F/U INFO IDENTIFIED THE PT'S PHYSICIAN HAS DETERMINED LEAD REPLACEMENT IS NOT NEEDED AS THE PT IS RECEIVING ADEQUATE STIMULATION COVERAGE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 77341 | OCTRODE | SCS LEAD | LGW | ST JUDE MEDICAL - NEUROMODULATION | 3186 | 3637214 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Required Intervention | IMPLANT DATE:| SCS IPG: MODEL 3788| SCS EXTENSION: MODEL 3383 (2)| IMPLANT DATE: |