BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT PACEMAKER ELECTRODE

    MDR report key: 17519215 · Received August 12, 2023

    Report

    Report Number
    MW5126163
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    September 6, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    TECHNICAL SERVICES RECEIVED A CALL ON (B)(6) 2012. CALLER REPORTED LV IMPEDANCE ON THIS UNKNOWN EPICARDIAL LEAD IS 220 OHMS. IT IS ASSUMED TO BE A MEDTRONIC LEAD. ALL MEASUREMENTS ARE GREAT, PACING LESS THAN 1 V AND LARGE R WAVES IN LV. TECHNICAL SERVIES SUGGESTED A NORMAL FOLLOW-UP OR CONTACT MEDTRONIC AND SEE IF L V LEAD IS THEIRS AND WHAT THEY RECOMMEND. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. 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
    2233921 PERMANENT PACEMAKER ELECTRODE PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown