BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2831830 · Received November 9, 2012

    Report

    Report Number
    1627487-2012-14016
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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

    RESULTS: THE COMPLAINT WAS NOT CONFIRMED. THE LEADS WERE RETURNED CLEAR AND UNDAMAGED AND PASSED ALL FUNCTIONAL TESTS. 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-14017. THE PATIENT HAD TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT EXPERIENCED SEVERE MUSCLE CRAMPING DURING A PERMANENT IMPLANT PROCEDURE. INTRAOPERATIVE TESTING OF THE LEADS RESULTED IN NO STIMULATION. X-RAYS WERE TAKEN AND SHOWED BOTH LEADS WERE ANTERIOR. MULTIPLE ATTEMPTS TO REPOSITION THE LEADS AND REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE AND CAUSED MUSCLE CRAMPING AND DISCOMFORT TO THE PATIENT. ADDITIONAL TESTING SHOWED LOW IMPEDANCES ON ALL CONTACTS OF ONE OF THE LEADS. THE PHYSICIAN REMOVED BOTH LEADS AND THE EXTENSION AND ABORTED THE IMPLANT PROCEDURE. THE PROCEDURE WAS EXTENDED AN ADDITIONAL 1-1.5 HOURS. THE PATIENT HAD NO ISSUES IN RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3695472

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention