BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 17517192 · Received August 11, 2023

    Report

    Report Number
    MW5124141
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    October 6, 2011
    Report Date
    November 3, 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 10/06/2011. CALLER STATED THAT THIS RV LEAD IMPEDANCE WENT UP A BIT. LAST TIME IT WAS 357 OHMS AND TODAY, 10/06/2011, IT WAS 464 OHMS, SENSING WAS FINE AND WAS NOT ABLE TO GET THRESHOLDS DUE TO RAPID HEART RATE. PHYSICIAN WAS DR. (B)(6) AT (B)(6) HOSPITAL IN (B)(6). 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
    2176655 UNKNOWN PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC 4194

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown