BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 3040734 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01574
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN ATTEMPT WAS MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, 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 BUILDUP OF INTERNAL BATTERY IMPEDANCE. ANALYSIS NOTED THAT THE DEVICE HAD NOT DECLARED EOL.

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INFORMATION WAS RECEIVED THAT THE DEVICE REACHED END OF LIFE (EOL) ONE MONTH LATER. AN INVASIVE PROCEDURE WAS PERFORMED. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. INITIAL ANLAYSIS PERFORMED AT OUR POST MARKET QUALITY ASSURANCE LABORATORY NOTED THAT THE DEVICE DID NOT MEET LONGEVITY EXPECTATIONS. ANALYSIS OF THE RETURNED PRODUCT IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRESENTED FOR A ROUTINE IN-CLINIC FOLLOW UP WITH REPORT THAT THE DEVICE EMITTED BEEPING TONES. INTERROGATION OF THE DEVICE REVEALED THAT ELECTIVE REPLACEMENT INDICATOR (ERI) HAD BEEN REACHED DUE TO AN EXTENDED CHARGE TIME, EXCEEDING THE EXTENDED CHARGE TIME LIMIT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TIME TO END OF LIFE (EOL). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142983 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR 0154| 4469| T167| 1861