FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 4092134
·
Received September 3, 2014
Report
- Report Number
- 1627487-2014-20182
- Event Type
- Injury
- Date Received
- September 3, 2014
- Date of Event
- January 19, 2008
- Report Date
- August 13, 2014
- Manufacturer
- ST. JUDE MEDICAL ¿ NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, 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
IT WAS REPORTED THE PATIENT'S SCS SYSTEM WAS EXPLANTED DUE TO POSITIONAL AND INEFFECTIVE STIMULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535357 | OCTRODE | SCS LEAD | GZB | ST. JUDE MEDICAL ¿ NEUROMODULATION | 3186 | 46811 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other | SCS IPG: MODEL 3716| IMPLANT: |