BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3200935 · Received June 13, 2013

    Report

    Report Number
    3200935
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 12, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    DRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A SEMI-PERMANENT PACER WAS BEING INSERTED AND ALTHOUGH THE LEAD TESTED AND FUNCTIONED FINE USING ALLIGATORS, WHEN THE MEDTRONIC ADAPTER CABLE (#5487) WAS ATTACHED USING THE USUAL IS 1 CONNECTOR CAPTURE WAS ABSENT OR INTERMITTENT. A SECOND CABLE (DIFFERENT LOT #) WAS USED WITH SAME ISSUE. ATTENDING ELECTRO-PHYSIOLOGIST WAS ABLE TO DETERMINE THAT REPOSITIONING (SLIGHTLY PULLING BACK) THE CABLE IN THE CONNECTOR SEEMED TO FIX THE PROBLEM AND CAPTURE WAS ATTAINED AND MAINTAINED. A MEDTRONIC TECHNICAL REPRESENTATIVE, CAME INTO THE LAB AND OBSERVED THIS AND WILL REPORT THE EVENT TO MEDTRONIC. THIS PROBLEM SEEMED TO COME FROM INSERTING THE PIN "TOO FAR" OR PUSHING "TOO HARD" AND RELIEVED BY SLIGHTLY PULLING BACK. MEDTRONIC WILL HAVE A REPORT GENERATED WITH ANY SUGGESTIONS TO AVOID THIS IN THE FUTURE.======================MANUFACTURER RESPONSE FOR MEDTRONIC ADAPTER CABLE (#5487), MEDTRONIC ADAPTER CABLE (#5487) (PER SITE REPORTER)======================PENDINGWHAT WAS THE ORIGINAL INTENDED PROCEDURE?TEMPORARY PACEMAKER INSERTIONDEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NODEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269845 * CABLE, PACEMAKER DRO MEDTRONIC 5487 5117001
    269894 * CABLE, PACEMAKER DTE MEDTRONIC 5487 38785001

    Patients

    Seq Age Sex Outcome Treatment
    1 *