BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1950393 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22297
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    January 10, 2007
    Report Date
    November 12, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINICIAN PLANNED TO DISCUSS THE ISSUE WITH THE PHYSICIAN. AS OF TODAY, AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE WITHOUT FURTHER COMPLICATION. SHOULD BOSTON SCIENTIFIC RECEIVE ADDITIONAL INFORMATION RELATED TO THIS CLINICAL OBSERVATION, THIS EVENT WILL BE REOPENED AND UPDATED. BOSTON SCIENTIFIC RECEIVED NEW INFORMATION THAT THE DEVICE WAS EXPLANTED IN (B)(6) 2007 AND WAS REPLACED WITH A COMPETITIVE ICD. THE EXPLANTED DEVICE WAS RETURNED IN (B)(6) 2010 FOR LABORATORY ANALYSIS. UPON RECEIPT, INITIAL LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE DID NOT MEET EXPECTED LONGEVITY PREDICTIONS AS DESCRIBED IN DEVICE LABELING. A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, ERI WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE. THIS DEVICE IS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ((B)(6) 2007) ADVISORY POPULATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A CHARGE TIME OF 18.7 SECONDS WITH A MONITORING VOLTAGE OF 2.66 VOLTS. THE CLINICIAN WAS CONCERNED WITH THE LONG CHARGE TIMES. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THAT THESE DEVICES CAN HAVE EXTENDED CHARGE TIMES AT MIDDLE OF LIFE (MOL) BATTERY STATUS AND FAXED A PRODUCT UPDATE DISCUSSING THE ISSUE TO THE CLINICIAN. THE EXTENDED CHARGE TIME LIMIT FOR THIS DEVICE WAS 18.9 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T125

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)