BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1870716 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17066
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 23, 2010
    Report Date
    October 11, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE'S PROGRAMMED PARAMETER SETTINGS AND THERAPY HISTORY WERE USED TO ESTIMATE EXPECTED BATTERY USE TO DATE, THEN COMPARED TO ACTUAL USE. OUR INITIAL ANALYSIS SHOWED THIS DEVICE DID NOT MEET LONGEVITY EXPECTATIONS PER PROGRAMMED VALUES. ADDITIONAL ANALYSIS IS PENDING.

    Additional Manufacturer Narrative · 1

    THIS DEVICE'S REPORTING STATUS IS CHANGED TO SERIOUS INJURY FROM MALFUNCTION DUE TO EXPLANT WITH EARLY ERI STATUS SUSPECTED. ANALYSIS OF THE RETURNED DEVICE IS PENDING.

    Additional Manufacturer Narrative · 1

    UPON RETURN TO BOSTON SCIENTIFIC CRM'S (B)(4) LABORATORY, A REVIEW OF DEVICE MEMORY REVEALED THE DEVICE DECLARED ITS ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT. ADDITIONAL LAB ANALYSIS AND TESTING SHOWED ERI WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF DEVICE INTERNAL BATTERY IMPEDANCE. THE EOL (END OF LIFE) INDICATOR WAS NOT DECLARED WHILE THE DEVICE WAS IN SERVICE. TESTING CONFIRMED ALL DEVICE THERAPIES WERE AVAILABLE.

    Description of Event or Problem · 1

    THE DEVICE SUBSEQUENTLY WAS EXPLANTED AND REPLACED WITH NO REPORT OF ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE DISPLAYED AN ELECTIVE REPLACEMENT INDICATOR (ERI) ASSOCIATED WITH A MIDDLE OF LIFE 2 BATTERY MEASUREMENT AND AN EXTENDED CHARGE TIME THAT EXCEEDED SPECIFICATIONS. THIS DEVICE IS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY POPULATION COMMUNICATED 11/27/2007. IT ALSO WAS REPORTED THAT THE PATIENT WAS BELIEVED TO BE EXPERIENCING A PACED HEART RATE BELOW THE PROGRAMMED LOWER RATE LIMIT DUE TO PREMATURE VENTRICULAR CONTRACTIONS THAT COULD BE AFFECTING THE HEART RATE MEASUREMENT OR THE ATRIO-VENTRICULAR TIMING. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED, AND THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    THE DEVICE SUBSEQUENTLY WAS EXPLANTED AND REPLACED WITH NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T127

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR (B)(4)| (B)(4)| (B)(4)