FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 4060802
·
Received August 6, 2014
Report
- Report Number
- 1627487-2014-24077
- Event Type
- Injury
- Date Received
- August 6, 2014
- Date of Event
- July 14, 2014
- Report Date
- July 14, 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 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 PT'S TRIAL PROCEDURE WAS ABANDONED DUE TO THE PT'S ANATOMY. IT WAS ALSO REPORTED THE PT EXPERIENCED A HEADACHE POST-OPERATIVE WHICH RESOLVED THE SAME DAY WITHOUT INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 459550 | OCTRODE | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3086 | 4621103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |