BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITATRON T70 DR

    MDR report key: 2811517 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02432
    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
    MN, FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED A POWER ON RESET OF THE PARAMETERS, POSSIBLY CAUSED BY A BIT FLIP IN MEMORY. AFTER THE RESET, THE DEVICE RESTORED THE PROGRAMMED PARAMETERS FROM THE BACK UP EEPROM AND THE DEVICE WAS FUNCTIONING NORMALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A PARTIAL RESET. THE PROGRAMMED PARAMETERS WERE RESTORED AUTOMATICALLY FROM THE BACKUP MEMORY AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A PARTIAL RESET. THE PROGRAMMED PARAMETERS WERE RESTORED AUTOMATICALLY FROM THE BACKUP MEMORY AND 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
    1 VITATRON T70 DR IMPLANTABLE PULSE GENERATOR DXY IPG MFG SWITZERLAND T70A1

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R