BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA+ C SERIES DR

    MDR report key: 2812620 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02403
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    May 10, 2012
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. A POWER ON RESET HAD OCCURRED. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD GENERATED AN ERROR MESSAGE ON THE PROGRAMMER. IT WAS ALSO REPORTED THE ELECTRICAL RESET WAS RESOLVED NORMALLY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA+ C SERIES DR PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC S.A. C60A2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other