FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2780345
·
Received October 5, 2012
Report
- Report Number
- 1627487-2012-01805
- Event Type
- Injury
- Date Received
- October 5, 2012
- Date of Event
- February 1, 2012
- Report Date
- September 14, 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-1806. IT WAS REPORTED THE PT IS NO LONGER RECEIVING EFFECTIVE STIMULATION. AN SJM REP MET WITH THE PT AND REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. X-RAYS WERE TAKEN AND SHOWED THE PT'S LEAD HAS MIGRATED. SURGICAL INTERVENTION IS PENDING TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3308873 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention | SCS IPG: MODEL 3716| IMPLANT DATE: |