BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITATRON

    MDR report key: 2810647 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02419
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    February 7, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATE COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. CONFIRMED A POWER ON RESET OCCURRED WITH CLOCK STOP STATUS. THERE WERE NO ISSUES AFTER RESET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE DEVICE INTERROGATION, A POWER ON RESET WAS NOTED. THE DEVICE WAS RESET AND 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
    1 VITATRON PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY IPG MFG SWITZERLAND C70A3

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention