FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2894827
·
Received December 20, 2012
Report
- Report Number
- 1627487-2012-02874
- Event Type
- Injury
- Date Received
- December 20, 2012
- Date of Event
- November 29, 2012
- Report Date
- November 29, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- 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
THE PT RECEIVED TWO PERCUTANEOUS LEADS (FROM THE SAME LOT) AS PART OF HER SCS SYSTEM. IT WAS REPORTED THE PT FELL AND HER LEADS MIGRATED. IT WAS REPORTED SURGICAL INTERVENTION WILL BE UNDERTAKEN TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | R64462 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention | SCS IPG: MODEL 3716| IMPLANT DATE: |