BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOCARDIAL LEAD

    MDR report key: 5858667 · Received August 9, 2016

    Report

    Report Number
    2649622-2016-08345
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Date of Event
    May 12, 2016
    Report Date
    May 12, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P120017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) WITH HIGH IMPEDANCE AND A LEAD FRACTURE IS SUSPECTED. THE PATIENTS EPICARDIAL LEFT VENTRICULAR (LV) LEAD ALSO EXHIBITED HIGH IMPEDANCE LEVELS. THE RV LEAD WAS CAPPED AND REPLACED, WHILE THE LV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512442 MYOCARDIAL LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-53

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR