BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT PACEMAKER ELECTRODE

    MDR report key: 17520229 · Received August 12, 2023

    Report

    Report Number
    MW5127177
    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 08/03/2012 FROM SALES REP. THE LEAD WAS IMPLANTED WITH POOR R WAVES AND HIGH THRESHOLDS. LEAD DISLODGED AFTER CASE AND PT HAD TO UNDERGO REVISION PROCEDURE. RV LEAD WAS REPOSITIONED. NO PHYSICIAN OR HOSPITAL KNOWN. 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
    2192829 PERMANENT PACEMAKER ELECTRODE PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown