BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC III PROTECT

    MDR report key: 1662122 · Received April 20, 2010

    Report

    Report Number
    6000094-2010-00720
    Event Type
    Death
    Date Received
    April 20, 2010
    Date of Event
    February 29, 2008
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. THERE IS NO ALLEGATION FROM A HEALTHCARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. IT IS NOT KNOWN IF THE DEVICE WAS EXPLANTED POST-MORTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED DURING THE IMPLANT SURGERY DUE TO THE PATIENT'S HEART FAILURE BECOMING WORSE AFTER DEF TEST. THE PATIENT DIED OF VF. ADDITIONAL INFORMATION INDICATES THAT THE PATIENTS DEATH DIDN'T RELATE TO OUR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC III PROTECT IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. 7285 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O