FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 4093641
·
Received September 4, 2014
Report
- Report Number
- 1627487-2014-20189
- Event Type
- Injury
- Date Received
- September 4, 2014
- Date of Event
- August 14, 2012
- Report Date
- August 14, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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
DEVICE 2 OF 2. REFERENCE MFR. REPORT: 1627487-2014-24088. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE THERAPY, IN TURN SHE DID NOT USED HER SCS SYSTEM IN COUPLE OF YEARS. THE PATIENT HAS REQUESTED A SCS SYSTEM EXPLANT. THE PATIENT HAS 3 SCS LEADS. TWO OF THEM HAVE THE SAME LOT NUMBER. IT IS UNKNOWN WHICH ONE IS RELATED TO THE ISSUE. THEREFORE, ALL OF THEM ARE BEING REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 542163 | OCTRODE | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 48908 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other | SCS IPG: MODEL 3716| IMPLANT DATE: |