BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT PACEMAKER ELECTRODE

    MDR report key: 17523870 · Received August 12, 2023

    Report

    Report Number
    MW5130818
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    December 17, 2013
    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) 1999 AND REMAINS IMPLANTED AT THIS TIME. THE PHYSICIAN WAS DR. (B)(6) AT (B)(6) CENTER IN (B)(6). A CALL TO TECHNICAL SERVICES ON 10/18/2013 STATES THAT PATIENT HAD EPISODES ON RV NON-CAPTURE. DEVICE WAS INTERROGATED AND NOTICED THAT PATIENT THRESHOLD VARIES WHEN PATIENT ASSUMED DIFFERENT POSITIONS. OUTPUTS WERE SET TO 2.2VAT 1.0MSEC AND THRESHOLD RANGED FROM 0.8V AT 1.0MES TO 2.0 AT1 .0 MSEC. UNIPOLAR WAS TESTED AND GOT THRESHOLDS OF 1.3 AT 1 .0 MSE. 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
    2244546 PERMANENT PACEMAKER ELECTRODE PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC 5024

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown