BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT PACEMAKER ELECTRODE

    MDR report key: 17531530 · Received August 12, 2023

    Report

    Report Number
    MW5138444
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    October 17, 2018
    Manufacturer
    MEDTRONIC
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS RA LEAD WAS IMPLANTED ON (B)(6) 2017 AND REMAINS IMPLANTED AT THIS TIME. A CALL WAS PLACED TO TECHNICAL SERVICES ON 08/20/2018 STATING THAT ON (B)(6) 2018 THERE WAS NOISE SEEN ON THE SAID LEAD. RA NOISE INTERVALS WERE NOT 108, 150, 375 MILLISECONDS. NO KNOWN PHYSICIAN AND FACILITY GIVEN. NO OTHER 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
    1216577 PERMANENT PACEMAKER ELECTRODE PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC 4076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown