FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2881385
·
Received December 17, 2012
Report
- Report Number
- 1627487-2012-03856
- Event Type
- Injury
- Date Received
- December 17, 2012
- Date of Event
- August 8, 2012
- Report Date
- August 8, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- 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 INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
THE PT RECEIVED 2 SCS LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT UNDERWENT A LEAD REPLACEMENT DUE TO NO LONGER RECEIVING INEFFECTIVE STIMULATION. THE ISSUE HAS BEEN RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3382913 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention | IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| SCS LEAD: MODEL 1192 (2) |