BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA+ C SERIES DR

    MDR report key: 1864980 · Received October 12, 2010

    Report

    Report Number
    6000094-2010-01956
    Event Type
    Injury
    Date Received
    October 12, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    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 PATIENT SUFFERED FROM MANY SYNCOPE EPISODES, WAS BROUGHT UNCONSCIOUS TO THE HOSPITAL WITH IRREGULAR HEART RATES AND THE PHYSICIAN DIAGNOSED "PACEMAKER FAILURE". IT WAS ALSO REPORTED THAT THE PATIENT "SUFFERED MENTALLY, PHYSICALLY AND FINANCIALLY." THE DEVICE WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA+ C SERIES DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. C50A3 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention