BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE PACEMAKER PULSE-GENERATOR

    MDR report key: 17537413 · Received August 12, 2023

    Report

    Report Number
    MW5144291
    Event Type
    Injury
    Date Received
    August 12, 2023
    Report Date
    July 29, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    DXY
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS LEAD WAS IMPLANTED IN 2005 AND REMAINS IMPLANTED AT THIS TIME. THIS IS NOTED ON (B)(6) 2014 DUE TO INCREASE IN LEAD IMPEDANCE SINCE APRIL FROM 500 OHMS TO 1500 OHMS. THE THRESHOLD WAS AT 2.2V AT 0.4MS AND WAS PROGRAMMED TO 2.5V AT 0.4MS. THE ECHOCARDIOGRAM SHOWED LOSS OF CAPTURE. THE LEAD WAS TESTED IN UNIPOLAR PACING AND THRESHOLD WAS AT 0.6V AT 1.0MS HOWEVER WHEN TESTED A FEW TIMES IT WAS STABLE AT 1.0MS. THERE IS NO R WAVE SENSE DURING THE TEST. THE OUTPUT WAS THEN INCREASED TO 5V AT 1 .OMS. MUSCLE TWITCHING IS NOTICED AT THIS OUTPUT. THE MEDICAL TEAM WAS ADVISED TO HAVE THE LEAD REPLACED AS SOON AS POSSIBLE AS THERE WAS DOUBT THAT THERE WAS LEAD FRACTURE. THE PATIENT WILL BE MONITORED AT ALL TIMES SINCE HE IS PACEMAKER DEPENDENT. THE PHYSICIAN WAS UNKNOWN. THE HEALTHCARE FACILITY WAS AT (B)(6) . NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050912 IMPLANTABLE PACEMAKER PULSE-GENERATOR IMPLANTABLE PACEMAKER PULSE-GENERATOR DXY MEDTRONIC 5038

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown