BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 17522252 · Received August 12, 2023

    Report

    Report Number
    MW5129200
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    August 25, 2011
    Report Date
    October 6, 2011
    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 08/25/2011. CALLER STATED THAT UNDERSENSING WAS NOTED WITH PACING INTO THE RHYTHM ON THIS RA LEAD. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. LEAD REMAINS IN SERVICE. 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
    595853 UNKNOWN PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown