FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 4093601
·
Received September 4, 2014
Report
- Report Number
- 1627487-2014-05625
- Event Type
- Injury
- Date Received
- September 4, 2014
- Date of Event
- August 11, 2014
- Report Date
- August 12, 2014
- 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 HAD TWO LEADS FROM THE SAME LOT. IT WAS REPORTED THE PT'S SCS SYSTEM WAS EXPLANTED DUE TO HER NO LONGER RECEIVING EFFECTIVE THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 541583 | OCTRODE | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3858971 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other | IMPLANT: 01/01/2012| SCS IPG, MODEL: 3788 |