BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTAK RENEWAL

    MDR report key: 1709385 · Received June 3, 2010

    Report

    Report Number
    2124215-2010-11989
    Event Type
    Death
    Date Received
    June 3, 2010
    Date of Event
    October 21, 2009
    Report Date
    May 11, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0863-05
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM THE PATIENT'S WIFE THAT THE PATIENT HAD PASSED AWAY. THE PATIENT'S WIFE ALLEGED THAT THE DEVICE KICKED THE PATIENT TO DEATH. AS OF TODAY, NO INFORMATION IS AVAILABLE IN REGARD TO THE CAUSE OF DEATH. THERE HAVE BEEN NO ALLEGATIONS AGAINST THE DEVICE RECEIVED FROM ANY MEDICAL PROFESSIONAL. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION FROM A LOCAL FIELD REPRESENTATIVE (FR) WAS MADE. THE FR WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H219

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death H219| 4518| 4086| 0185