BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTAK RENEWAL 3 RF HE

    MDR report key: 1001904 · Received February 22, 2008

    Report

    Report Number
    2124215-2008-99867
    Event Type
    Death
    Date Received
    February 22, 2008
    Date of Event
    January 24, 2008
    Report Date
    February 22, 2008
    Manufacturer
    CLONMEL
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. THE BOSTON SCIENTIFIC CRM TECHNICAL SERVICES DEPARTMENT ANALYZED THE 'SAVE TO DISK' INFO, AND CONCLUDED THAT DUE TO THE PT'S VARIABLE VT, THE DEVICE DID NOT SENSE THE FINAL AGONAL RHYTHM AS A TREATABLE ARRHYTHMIA, AND ONLY ANTI-TACHYCARDIA PACING (ATP) WAS GIVEN WITH NO SHOCK THERAPY DELIVERED. THE DEVICE APPEARED TO ACT APPROPRIATELY PER ITS PROGRAMMED SETTINGS, AND A REVIEW OF ELECTROGRAMS FORM THE TIME OF DEATH DID NOT INDICATE THAT UNDERSENSING WAS OCCURRING. THE DEVICE WAS BURIED WITH THE PT. NO OFFICIAL CAUSE OF DEATH HAS BEEN GIVEN. BOSTON SCIENTIFIC CRM ENGINEERING ANALYSIS OF THE 'SAVE TO DISK' INFO CONCLUDED THAT THERE WERE NO DEVICE RESETS AND NO UNEXPECTED MEMORY CORRUPTIONS DETECTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CARDIAC RHYTHM MANAGEMENT (CRM) RECEIVED INFO THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PT HAS DIED. A 'SAVE TO DISK' WAS SENT TO THE BOSTON SCIENTIFIC CRM TECHNICAL SERVICES DEPARTMENT FOR REVIEW. THE PT'S RHYTHM APPEARED TO START OUT AS A JUNCTIONAL RHYTHM, AND THEN DETERIORATE INTO A POLYMORPHIC VENTRICULAR TACHYCARDIA (VT), AND TO AN AGONAL RHYTHM FOR WHICH NO SHOCK WAS GIVEN. A HEALTHCARE PROFESSIONAL CLAIMED THAT DEVICE UNDERSENSING LED TO THE PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL 3 RF HE IMPLANTABLE CHF GENERATOR NIK CLONMEL H217

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death 4472/201659| 1861/226706| 6482/027238| 4543/120394| 0154/357816