BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTAK PRIZM 2

    MDR report key: 1716917 · Received June 10, 2010

    Report

    Report Number
    2124215-2010-12371
    Event Type
    Death
    Date Received
    June 10, 2010
    Date of Event
    January 13, 2010
    Report Date
    May 12, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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 A PATIENT ADVOCATE THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD PASSED AWAY DUE TO HEART AND RENAL FAILURE. THE PATIENT ADVOCATE STATED THAT THE PATIENT'S HEART WOULD STOP AND THE ICD WAS NOT WORKING. IT WAS REPORTED THAT THE PATIENT NEEDED A NEW DEVICE NEAR THE TIME OF HIS PASSING BUT THAT THE PATIENT WAS NOT HEALTHY ENOUGH TO RECEIVE A NEW DEVICE. THE PATIENT ADVOCATE HAD NUMEROUS QUESTIONS REGARDING THE CAPABILITIES AND FUNCTION OF PULSE GENERATORS. A TECHNICAL SERVICE (TS) CONSULTANT ADDRESSED THE ADVOCATE'S QUESTIONS. FROM THE CONVERSATION, THE TS CONSULTANT SURMISED THAT THE PATIENT'S ICD HAD PASSED ELECTIVE REPLACEMENT INDICATOR AND/OR END OF LIFE AND THAT THE PHYSICIAN INVOLVED IN THE PATIENT'S CARE DECIDED NOT TO REPLACE THE ICD BASED ON THE PATIENT'S CLINICAL STATUS. THERE WERE NO ALLEGATIONS FROM ANY PHYSICIAN OR HEALTH CARE PROVIDER THAT A DEVICE MALFUNCTION PLAYED A ROLE IN THE PATIENT'S DEATH. AN ATTEMPT TO CONTACT THE LOCAL FIELD REPRESENTATIVE (FR) WAS MADE. THE FR WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE PASSING OF THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1861

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death 0148| 4470| 1861