BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 2050262 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03938
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 17, 2011
    Report Date
    May 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM NOR DENY THIS REPORTED CLINICAL ALLEGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, INTERROGATION REVEALED THIS DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATORS (ERI) AND DISPLAYED CHARGE TIMES OF 25.6 SECONDS AND 2.5 V. ONE MONTH EARLIER, IT WAS THOUGHT THIS DEVICE HAD TWO MONTHS REMAINING LONGEVITY. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED REGARDING THE REASON FOR THIS DEVICE REACHING ERI EARLIER THAN EXPECTED. INFORMATION WAS PROVIDED THAT THIS DEVICE IS NOT INCLUDED IN AN ADVISORY AND LIKELY DECLARED ERI DUE TO EXTENDED CHARGE TIME BEHAVIOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WITH THIS DEVICE PASSED AWAY DUE TO END-STAGE HEART FAILURE. THIS DEVICE WAS NOT REPLACED DUE TO THE PATIENT'S WORSENING CONDITION. THE PHYSICIAN DID NOT FEEL THIS DEVICE CONTRIBUTED TO THE PATIENT'S DEATH. IT IS UNKNOWN WHETHER THIS DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1870

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death 1852| 1870| 6945