BEUDAMED
    FDA Adverse Event Death Summary report: N

    COGNIS

    MDR report key: 1981864 · Received February 8, 2011

    Report

    Report Number
    2124215-2011-02343
    Event Type
    Death
    Date Received
    February 8, 2011
    Date of Event
    January 9, 2011
    Report Date
    January 9, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WHO RECEIVED THIS DEVICE (AS A REPLACEMENT DUE TO NORMAL BATTERY DEPLETION) PASSED AWAY 18 DAYS AFTER IMPLANT. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THERE WERE NO ALLEGATIONS AGAINST THE DEVICE AT THE TIME HE WAS ASKED BY THE PATIENT'S PHYSICIAN TO PROGRAM THE DEVICE OFF DUE TO THE PATIENT'S DEATH. 11 DAYS AFTER THE REPLACEMENT PROCEDURE, THE PATIENT'S SPOUSE HAD REPORTED TO A BOSTON SCIENTIFIC CUSTOMER SERVICE CONSULTANT THAT THE PATIENT HAD BEEN HOSPITALIZED IN CRITICAL CARE DUE TO THE DEVICE REPLACEMENT. THE SPOUSE ALSO SAID THE PATIENT HAD BEEN TAKEN OFF COUMADIN SEVEN DAYS BEFORE DEVICE REPLACEMENT, THAT THE DECEASED HAD EXPERIENCED INTERNAL BLEEDING AFTER DEVICE REPLACEMENT, AND THAT HE WAS HOSPITALIZED WITH ONE PINT OF BLOOD LEFT IN HIS SYSTEM. THE REPRESENTATIVE SUBSEQUENTLY REPORTED THAT MEASUREMENTS WERE FINE DURING THE DEVICE CHECK AT IMPLANT, THAT THE PATIENT WAS STILL IN THE OPERATING ROOM WHEN HE LEFT AND THERE WERE NO ISSUES, AND THAT THE PATIENT HAD OTHER MEDICAL PROCEDURES SCHEDULED LATER THE SAME DAY AFTER THE DEVICE REPLACEMENT. WHEN THE REPRESENTATIVE PRESENTED TO PROGRAM THE DEVICE OFF, HE WAS TOLD THE PATIENT HAD EXPERIENCED COMPLICATIONS DUE TO THE PROCEDURES, AND THAT HE WAS NOT AWARE OF ANY CONCERNS REGARDING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death 0158| 4525| N118