BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3850697 · Received May 21, 2014

    Report

    Report Number
    1627487-2014-12371
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION: THE LEADS WERE CUT DURING THE EXPLANT PROCEDURE. ONE OF THE STIMULATION END SEGMENTS HAD AN OUTER TUBING BREACH WHERE THE INTERNAL WIRES WERE PULLED THROUGH. THE LEAD BODY WAS SEVERELY DAMAGED DURING THE EXPLANT PROCEDURE. CONTINUITY WAS NOT PERFORMED ON THIS SEGMENT OF THE LEADS. THE OTHER 3 SEGMENTS WERE TESTED FOR CONTINUITY AND NO OPENS WERE FOUND. THE REPORTED INEFFECTIVE STIMULATION WAS NOT CONFIRMED. 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

    IT WAS REPORTED THE PATIENT'S DEVICES WERE RETURNED TO ST. JUDE MEDICAL WITH A NOTE THAT READ "NOT GETTING PAIN RELIEF AND THE LEADS WERE CAUSING PAIN." THE IMPLANTING PHYSICIAN WAS CONTACTED. THE PATIENT HAS NOT BEEN SEEN BY THE PHYSICIAN SINCE 2011 AND THEY DO NOT KNOW WHO PERFORMED THE EXPLANT. NOTE THE PATIENT RECEIVED TWO LEADS FROM THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303386 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3101876

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other IMPLANT:| SCS IPG: MODEL 3788