BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3133646 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-15661
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 PATIENT HAS 2 LEADS (FROM THE SAME LOT) IMPLANTED AS PART OF HER SCS SYSTEM. IT WAS REPORTED THE PATIENT'S STIMULATION CHANGED SUBSEQUENT TO BEING INVOLVED IN AN AUTOMOBILE ACCIDENT. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND REPROGRAMMING WAS UNSUCCESSFUL. X-RAYS WERE TAKEN AND INDICATED THE LEAD HAD MIGRATED. THE NEXT COURSE OF ACTION IS UNDETERMINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223508 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3923738

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE: