BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL CABLE

    MDR report key: 3963648 · Received May 16, 2014

    Report

    Report Number
    1627487-2014-00299
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    January 31, 2014
    Report Date
    April 24, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - COMPLAINT WAS CONFIRMED FOR "LOOSE CONNECTION". AS RECEIVED, A LOOSE CONNECTION WAS OBSERVED WHEN PATIENT SCENARIO WAS RECREATED WITH TEST CONTROL LEADS. TEST LEADS WERE INSERTED INO THE RETURNED THE CABLE AND LEAD PULLED OUT WAS OBSERVED; CONSISTENT WITH OBSERVATION MADE IN THE FIELD. 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 ((B)(6)) TRIAL LEAD WOULD NOT STAY CONNECTED TO THE TRIAL CABLE. DESPITE NUMEROUS ATTEMPTS TO SECURE THE CONNECTION, THE LEAD CONTINUED TO PULL OUT FROM THE TRIAL CABLE. A NEW TRIAL CABLE WAS USED TO COMPLETE THE TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294137 TRIAL CABLE SCS LEAD ACCESSORY GZB ST. JUDE MEDICAL - NEUROMODULATION 3009 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SCS LEAD: MODEL 3186| IMPLANT DATE: