BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITATRON DA+ T-SERIES DR

    MDR report key: 4970922 · Received August 5, 2015

    Report

    Report Number
    6000095-2015-00006
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    May 2, 2015
    Report Date
    May 2, 2015
    Manufacturer
    VITATRON MEDICAL B.V.
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US 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 DURING INTERROGATION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD THE REMAINING DEVICE LONGEVITY WAS NOT SHOWN, AND AN ERROR MESSAGE WAS DISPLAYED DUE TO UNEXPECTED BATTERY CAPACITY. THE ICD REMAINS IN USE WITH RECOMMENDATION TO MONITOR PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517702 VITATRON DA+ T-SERIES DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY VITATRON MEDICAL B.V. T60A1

    Patients

    Seq Age Sex Outcome Treatment
    1