BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2042457 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01363
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 18, 2011
    Report Date
    March 17, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-08 TO Z-0053-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    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. THE DEVICE LATER DECLARED END OF LIFE (EOL) AFTER EXPERIENCING ONE CHARGE TIME GREATER THAN 30 SECONDS. 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 (NOVEMBER 27, 2007) ADVISORY POPULATION.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS DEVICE WAS EXPLANTED AND REPLACED. THIS DEVICE HAS BEEN RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEVICE DECLARED THE BATTERY STATUS ELECTIVE REPLACEMENT INDICATORS (ERI) ON (B)(6), 2011 WITH A MONITORING VOLTAGE OF 2.70 VOLTS AND EXTENDED CHARGE TIME OF 22 SECONDS. CURRENTLY THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DEVICE DECLARED END OF LIFE (EOL) WITH A MONITORING VOLTAGE OF 2.68V AND A CHARGE TIME OF 35 SECONDS. THERE WAS A CONCERN THE DEVICE REACHED EOL PREMATURELY. TECHNICAL SERVICES DISCUSSED THE DEVICE REACHED EOL DUE TO CHARGE TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention T177| 0158