BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL CABLE

    MDR report key: 3963624 · Received May 16, 2014

    Report

    Report Number
    1627487-2014-03359
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    December 18, 2013
    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
    TX, US
    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 INTO THE RETURNED THE CABLE AND LEAD PULL 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

    THIS ISSUE IS RELATED TO 2 TRIAL CABLES WITH THE SAME LOT NUMBER. IT WAS REPORTED AFTER THE PATIENT'S TRIAL PROCEDURE, WHEN CONNECTING THE TRIAL SCS LEADS TO THE TRIAL CABLES, THE LEADS KEPT SLIPPING OUT OF THE CONNECTION. THE TRIAL CABLES WERE REPLACED WITH NEW CABLES WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293815 TRIAL CABLE SCS TRIAL CABLE GZB ST. JUDE MEDICAL - NEUROMODULATION 3009 4326199

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR