BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYODEX STEROID ELUTING BIPOLAR PACING LEAD, 54CM

    MDR report key: 8412214 · Received March 12, 2019

    Report

    Report Number
    2183787-2019-00020
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Report Date
    March 4, 2019
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    DURING THE FOLLOW-UP, THE DOCTOR NOTED THAT THE SENSING CHANNEL LEFT VENTRICULAR LEAD (GREATBATCH MEDICAL LEAD) WAS DECREASED AND THRESHOLD INCREASED. BY FLUOROSCOPY, THE DOCTOR SAW THAT THE LEAD IS DISLOCATED (GREATBATCH MEDICAL LEAD DISLODGED). THE DOCTOR DECIDED TO MODIFY THE DEVICE PROGRAMMING BY PROGRAMMING ONLY THE RIGHT STIMULATION. THE GREATBATCH MEDICAL LEAD WAS ISOLATED AND WAS PROGRAMMED OFF. THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205240 MYODEX STEROID ELUTING BIPOLAR PACING LEAD, 54CM BIPOLAR EPICARDIAL LEAD DTB GREATBATCH MEDICAL 1084T-54 W3510427

    Patients

    Seq Age Sex Outcome Treatment
    1