BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3110904 · Received May 8, 2013

    Report

    Report Number
    1627487-2013-08075
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 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 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. REFERENCE MFR REPORT NUMBER: 1627487-2013-08074. IT WAS REPORTED THE PATIENT HAD AN INEFFECTIVE STIMULATION. ATTEMPTED REPROGRAMMING DID NOT HELP TO OBTAIN AN IDEAL COVERAGE. X-RAY IMAGERY SHOWED THE LEADS MAY HAVE MIGRATED ONE VERTEBRAL LEVEL UP AND THE PHYSICIAN ADDRESSED THE ISSUE BY LEAD REVISION. FOLLOW-UP INFO IDENTIFIED THE PATIENT HAD THE DESIRED COVERAGE AND THE THERAPY WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202447 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL- NEUROMODULATION 3186 3932310

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE:| SCS ANCHOR: MODEL 1192| IMPLANT DATE: