BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT PACEMAKER ELECTRODE

    MDR report key: 17521856 · Received August 12, 2023

    Report

    Report Number
    MW5128804
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    February 2, 2012
    Manufacturer
    PACESETTER
    Product Code
    DTB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    TECHNICAL SERVICES RECEIVED A CALL ON 01/04/2012 FROM SALES REP. THRESHOLD IS 2.8/0.7 FOR ACTIVE LEAD WHICH REP THOUGHT WAS 1226T. PATIENT HAD CHB AND THEY ARE TRYING TO DETERMINE WHETHER OR NOT TO CONTINUE USING THE EXISTING LEAD. 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
    868962 PERMANENT PACEMAKER ELECTRODE PERMANENT PACEMAKER ELECTRODE DTB PACESETTER 1226T

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown