BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTAK RENEWAL

    MDR report key: 2851432 · Received November 29, 2012

    Report

    Report Number
    2124215-2012-15989
    Event Type
    Death
    Date Received
    November 29, 2012
    Date of Event
    August 12, 2009
    Report Date
    November 7, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE PASSED AWAY APPROXIMATELY THREE YEARS AGO, WHILE HOSPITALIZED FOR A PLANNED, NON-CARDIAC RELATED PROCEDURE. THE PATIENT WAS NON-RESPONSIVE TO CARDIOPULMONARY RESUSCITATION EFFORTS. CLINICAL INFORMATION TO DATE STATES THE BOSTON SCIENTIFIC DEVICE WAS NOT INVOLVED IN THE EVENT AND THE DEATH WAS REPORTED AS 'PATIENT RELATED'. HOWEVER, THE CLINICAL INVESTIGATOR REPORTED A POSSIBLE ASSOCIATION BETWEEN THE DEVICE AND THE PATIENT'S DEATH. THE MEDICAL FACILITY DID NOT PERFORM A POST-MORTEM INTERROGATION AND THE DEVICE WAS NEVER RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H190

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| H H190| 0185| 4096| 4555