BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2040938 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00821
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    July 28, 2010
    Report Date
    January 21, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND WAS SUCCESSFULLY INTERROGATED BY BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. ENGINEERING CALCULATIONS DETERMINED THAT THIS DEVICE DID NOT MEET EXPECTED LONGEVITY. THE DEVICE IS CURRENTLY UNDERGOING DETAILED ANALYSIS TO DETERMINE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    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. PACING, SENSING, AND SHOCKING FUNCTIONS WERE VERIFIED PER BENCH TOP TESTING. THE RECORDED PACING AND SHOCK IMPEDANCE MEASUREMENT FROM THE PROGRAMMER WAS WITHIN NORMAL LIMITS. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION IN (B)(6) 2010 THAT THIS CLINIC NURSE CONTACTED TECHNICAL SERVICES THAT THIS DEVICE WAS EXHIBITING A MONITORING VOLTAGE OF 2.96 VOLTS ASSOCIATED WITH A CHARGE TIME OF 9.0 SECONDS. IN (B)(6) 2010, THE MONITORING VOLTAGE DECREASED TO 2.78 VOLTS AND WAS ASSOCIATED WITH A CHARGE TIME OF 16. 1 SECONDS. TECHNICAL SERVICES DISCUSSED THE MID-LIFE BEHAVIOR OF THIS DEVICE AND ELECTIVE REPLACEMENT INDICATOR TRIGGERS. TECHNICAL SERVICES RECOMMENDED A NORMAL FOLLOW-UP SCHEDULE. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES IN (B)(6) 2011 TO REPORT THAT THE DEVICE TRIGGERED ERI ASSOCIATED WITH A MONITORING VOLTAGE WAS 2.62 VOLTS AND A CHARGE TIME OF GREATER THAN 22 SECONDS. THE PHYSICIAN EXPRESSED DISSATISFACTION WITH THE DEVICE LONGEVITY AND CHARGE TIME PERFORMANCE. TECHNICAL SERVICES DISCUSSED MID-LIFE DEVICE BEHAVIOR AND BATTERY CHEMISTRY. THE DEVICE WAS EXPLANTED AND REPLACED. TO DATE, THE DEVICE HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 0185| T175