BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC MAXIMO

    MDR report key: 2021176 · Received March 16, 2011

    Report

    Report Number
    6000144-2011-01077
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    February 26, 2007
    Report Date
    March 2, 2022
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 "HAVE SUFFERED EXTREME PHYSICAL INJURIES, EXTREME EMOTIONAL AND PSYCHOLOGICAL DISTRESS WHICH INCLUDES SUDDEN DEATH AND DAMAGES FOR WHICH THEY ARE ENTITLED COMPENSATORY AND EQUITABLE DAMAGES AND DECLARATORY RELIEF IN AN AMOUNT TO BE PROVEN AT TRIAL". APPROXIMATELY TWO YEARS LATER, AN ALLEGATION FROM A SECOND ATTORNEY INDICATED THE PATIENT IMPLANTED WITH A RIGHT VENTRICULAR LEAD IS DECEASED AND NO FURTHER INFORMATION WAS PROVIDED. FURTHER ASSESSMENT OF THE MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED APPROXIMATELY SEVEN MONTHS POST IMPLANT OF THE IMPLANTABLE CARDIOVERSION DEFIBRILLATOR AND LEFT VENTRICULAR LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC MAXIMO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7304 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Death 1488TC COMPETITOR IMPLANTABLE PACING LEAD| 1488TC COMPETITOR IMPLANTABLE PACING LEAD