BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITALITY DS

    MDR report key: 1210805 · Received October 23, 2008

    Report

    Report Number
    2124215-2008-99944
    Event Type
    Death
    Date Received
    October 23, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 23, 2008
    Manufacturer
    CLONMEL
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECH SERVICES REVIEWED THE PRE-MORTEM EPISODE. ATRIAL ASYSTOLE WAS NOTED. UNDERSENSING OF A VENTRICULAR ARRHYTHMIA OCCURRED WITH A DEVICE DIVERT CHARGE OCCURRING DURING RECONFIRMATION. TECH SERVICES DISCUSSED THAT IT COULD BE PULSELESS ELECTRICAL ACTIVITY, BUT WITHOUT KNOWLEDGE OF THE MECHANICAL STATE OF THE PATIENT, IT CANNOT BE CONFIRMED. THE VENTRICULAR RHYTHM APPEARED TO HAVE RAPIDLY DETERIORATED, AND THE SHOCK EGM WAS FLAT AND UNDULATING, WITH AN AGONAL APPEARANCE. AS OF TODAY, THIS MEDICAL DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. IN FOLLOW UP WITH THE BSC REPRESENTATIVE, THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PASSED AWAY. THE BSC REPRESENTATIVE REPORTED THE CASE TO TECH SERVICES, NOTED THAT THERE WAS AN EPISODE ON THE DATE OF DEATH THAT INDICATED THE PATIENT WAS EITHER IN A FINE VENTRICULAR FIBRILLATION OR ASYSTOLE. THE DEVICE DID NOT TREAT. A SAVE-TO-DISK WAS SENT IN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY DS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CLONMEL T125

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 0158/104096| 4087/152291