FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 4092015
·
Received August 27, 2014
Report
- Report Number
- 1627487-2014-20166
- Event Type
- Injury
- Date Received
- August 27, 2014
- Date of Event
- August 7, 2014
- Report Date
- August 7, 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 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 TRIAL PROCEDURE WAS ABANDONED AS THE PHYSICIAN WAS NOT ABLE TO IMPLANT THE LEAD DUE TO SCAR TISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 518629 | OCTRODE | SCS LEAD | GZB | ST. JUDE MEDICAL, NEUROMODULATION | 3086 | 4617003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 MO | Other |