BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA+ T SERIES DR

    MDR report key: 2201592 · Received August 11, 2011

    Report

    Report Number
    6000094-2011-01330
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 10, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P990001/S15
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A WARNING ON THE PROGRAMMER SCREEN DUE TO THE DEVICE. IT WAS FURTHER REPORTED THAT THE DEVICE DID RESET DUE TO A WATCHDOG TIMEOUT AND THE DEVICE RESTORED TO THE PROGRAMMED SETTINGS AFTER THE RESET. 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 DA+ T SERIES DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. T60A1 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other