BEUDAMED
    FDA Adverse Event Other Summary report: N

    CABLE, PACEMAKER, EXTERNAL, SINGLE USE

    MDR report key: 2581399 · Received May 9, 2012

    Report

    Report Number
    2581399
    Event Type
    Other
    Date Received
    May 9, 2012
    Date of Event
    April 11, 2012
    Report Date
    May 9, 2012
    Manufacturer
    MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
    Product Code
    LDF
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BROUGHT TO CATH LAB DEPENDENT ON PACING, FOR PLACEMENT OF A SEMIPERMANENT PACER FOR COMPLETE HEART BLOCK. RIGHT VENTRICULAR (RV) PACING LEAD (MEDTRONIC NOVUS) WAS PLACED IN THE RV APEX. PACING THRESHOLD THROUGH ANALYZER WAS LESS THAN 1V AT 0.4 MS. LEAD WAS ATTACHED TO THE MEDTRONIC CABLE TO THE PACING BOX, BUT NO CAPTURE, NO SPIKES. SECOND PACING BOX WAS TRIED, NO CAPTURE, NO SPIKES. MEDTRONIC CABLE WAS REPLACED WITH A SECOND MEDTRONIC CABLE, AGAIN WITH NO CAPTURE AND NO SPIKES. A THIRD MEDTRONIC CABLE WAS THEN OPENED AND ATTACHED, WHICH WORKED. NOTHING DIFFERENT WAS DONE WHEN ATTACHING THE THIRD CABLE THAN WHEN ATTACHING THE PREVIOUS TWO. AFTER THESE EVENTS A SIMILAR SEQUENCE OF EVENTS WITH ANOTHER PATIENT WAS DESCRIBED ANECDOTALLY, HOWEVER AT THIS TIME WE DO NOT HAVE SPECIFICS ON THE SECOND CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CABLE, PACEMAKER, EXTERNAL, SINGLE USE LDF MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 5487 5015301
    2 CABLE, PACEMAKER, EXTERNAL, SINGLE USE LDF MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 5487 5015401

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR