BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITATRON T60 DR

    MDR report key: 2810919 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02459
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P990001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE INTERROGATION A WARNING APPEARED STATING "TO DO A SAVE TO DISK (STD) AND CONTACT THE REPRESENTATIVE". ADDITIONAL INFORMATION NOTED THAT THE DEVICE HAD A BIT FLIP AND A POWER ON RESET (POR). A MANUAL GUIDED RESET (MGR) WILL BE PERFORMED TO REPROGRAM THE DEVICE, HOWEVER, THIS HAS NOT YET OCCURRED. 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 FURTHER REPORTED THAT A MANUAL GUIDED RESET (MGR) HAS TAKEN PLACE 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 T60 DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC S.A. T60A2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention