BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA+ T SERIES DR

    MDR report key: 2951777 · Received February 9, 2013

    Report

    Report Number
    6000095-2013-00001
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 2, 2012
    Manufacturer
    VITATRON MEDICAL B.V.
    Product Code
    DXY
    PMA / PMN Number
    P990001/S15
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE LONGEVITY IS NOT AS LONG AS EXPECTED. THE DEVICE 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
    55590 DA+ T SERIES DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY VITATRON MEDICAL B.V. T60A1U

    Patients

    Seq Age Sex Outcome Treatment
    1