FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2892863
·
Received December 28, 2012
Report
- Report Number
- 1627487-2012-14277
- Event Type
- Injury
- Date Received
- December 28, 2012
- Date of Event
- January 19, 2012
- Report Date
- January 19, 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
DEVICE 2 OF 2. REF MFR REPORT: 1627487-2012-14276. IT WAS REPORTED THE PT'S TWO LEADS WERE REPLACED DUE TO MIGRATION. THE PT IS NOW RECEIVING EFFECTIVE STIMULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3395248 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention | SCS IPG: MODEL 3716| IMPLANT DATE: |