BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT PACEMAKER ELECTRODE

    MDR report key: 17521230 · Received August 12, 2023

    Report

    Report Number
    MW5128178
    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

    THIS RV LEAD WAS IMPLANTED ON (B)(6) 2000. A CALL TO TECHNICAL SERVICES (TS) STATES THAT THERE IS OVERSENSING ON THE V LEAD. CALLER MEASURED AMPLITUDE OF NOISE AND HIGHEST WAS 1.6-1.8MV. MOST OF NOISE WAS 0.6-0.9MV. CALLER GOING TO LEAVE RV SENSITIVITY AT 1 MV. V PACE IMPEDANCE 473 OHMS, 42 SLI, THRESHOLD 0.4V, SENSING 8MV. CALLER DID NOT FIND A OFT, THE EARLIEST EPISODE SAVED WAS AN EPISODE WITH A LOT OF NOISE. EPISODE WAS DIVERTED, NO THERAPY FOR NOISE. PATIENT HAS HAD NO PAUSES BECAUSE OF NOISE, PATIENT NOT DEPENDENT. TS STATED MAY WANT TO DO NIPS FOR PT TO MAKE SURE THAT WITH DECREASED SENSITIVITY CAN STILL APPROPRIATELY SENSE VF. CALLER WILL DISCUSS WITH MD WHO IS NOT KNOWN YET. 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
    2218088 PERMANENT PACEMAKER ELECTRODE PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC 6942

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown