BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITATRON DA+ T-SERIES DR

    MDR report key: 4967087 · Received August 4, 2015

    Report

    Report Number
    6000095-2015-00005
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    June 1, 2014
    Report Date
    May 14, 2015
    Manufacturer
    VITATRON MEDICAL B.V.
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Removal / Correction Number
    Z-1000-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS PRODUCT WAS INCLUDED IN A FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED IF THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) DEVICE WAS UNABLE TO MEASURE THRESHOLDS OVER THE PAST YEAR. EACH TIME IT EXHIBITED A PROGRAMMER ERROR. THE CLINICIAN THOUGHT IT WAS DUE TO THE FACT THAT THE DEVICE WAS "AGING". THE DEVICE HAS NOW REACHED ELECTIVE REPLACEMENT INDICATOR (ERI), AND IT 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
    509663 VITATRON DA+ T-SERIES DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY VITATRON MEDICAL B.V. T60A1B

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR