FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2932147
·
Received January 25, 2013
Report
- Report Number
- 1627487-2013-01102
- Event Type
- Injury
- Date Received
- January 25, 2013
- Date of Event
- January 4, 2013
- Report Date
- January 4, 2013
- Manufacturer
- ST. JUDE MEDICAL - NERUOMODULATION
- Product Code
- LGW
- 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
THE PT HAS TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT IS NOT RECEIVING EFFECTIVE STIMULATION IN HER BACK. AN SJM REP MET WITH THE PT AND REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. THE PT IS RECEIVING INJECTIONS FOR HER BACK, AND WILL CONTINUE REPROGRAMMING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 36146 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NERUOMODULATION | 3186 | 3422932 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention | SCS ANCHOR, MODEL 1192 (2)| SCS IPG, MODEL 3788| IMPLANT DATE:| IMPLANT DATE: |