FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 4132667
·
Received September 24, 2014
Report
- Report Number
- 1627487-2014-03631
- Event Type
- Injury
- Date Received
- September 24, 2014
- Date of Event
- September 2, 2014
- Report Date
- September 2, 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 PATIENT WAS NOT RECEIVING EFFECTIVE FOOT STIMULATION. AS A RESULT, THE SCS LEADS WERE EXPLANTED AND REPLACED WITH DIFFERENT MODEL LEADS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 595962 | OCTRODE | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 4003793 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other | SCS LEAD: MODEL 3788| IMPLANT DATE: |