BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2955285 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-00832
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    November 21, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD A WARNING FOR LOW IMPEDANCE. THE UNIPOLAR IMPEDANCE WAS ALSO HIGHER THAN THE BIPOLAR IMPEDANCE. THE 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
    59589 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5092-52

    Patients

    Seq Age Sex Outcome Treatment
    1 ADDR01 IMPLANTABLE PULSE GENERATOR