BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1951994 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23235
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    November 30, 2010
    Report Date
    March 23, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1513-08 TO Z-1514-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT FROM ANALYSIS, A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE 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. EOL WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE. IN REGARDS TO TONES THAT WERE MENTIONED IN THE FIELD, TECHNICIANS NOTED THIS WAS DUE TO THE DEVICE DECLARING ELECTIVE REPLACEMENT INDICATOR (ERI) AND THEN DECLARING EOL WHILE IMPLANTED, WHICH IS CONSIDERED TO BE NORMAL DEVICE FUNCTION.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    WHEN ANALYSIS IS COMPLETE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) 12 WEEKS AGO. THE BEEPING TONES WERE TURNED OFF AND NOW THE DEVICE HAS REACHED END OF LIFE (EOL) AND IS BEEPING AGAIN. MONITORING VOLTAGE WAS 2.66 AND EXTENDED CHARGE TIMES WERE 30 SECONDS. THE PATIENT IS UNHAPPY AS THEY THOUGHT, PER THEIR LAST DEVICE CHECK, THE DEVICE LONGEVITY HAD MORE THAN A YEAR REMAINING.

    Description of Event or Problem · 1

    THREE MONTHS LATER THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR 0185| 4087| T167