BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC SENTRY

    MDR report key: 2021155 · Received March 16, 2011

    Report

    Report Number
    6000094-2011-00357
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    October 14, 2005
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE LEAD MODEL 6949 IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT DIED APPROXIMATELY NINE MONTHS POST IMPLANT OF THE RIGHT VENTRICULAR LEAD. IT WAS ALSO NOTED THE PATIENT SUFFERED EXTREME PHYSICAL INJURY AND MENTAL ANGUISH. FURTHER REVIEW OF THE EVENT REVEALED THE PATIENT DIED NINE MONTHS POST INITIAL IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY WITH DEFIBRILLATOR CAN, THE RIGHT ATRIAL AND LEFT VENTRICULAR LEADS AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC SENTRY IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. 7297 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death