BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2153551 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06309
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 21, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL IS AVAILABLE AND AT THIS TIME, OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ANALYSIS IS CURRENTLY ON-GOING. WHEN ADDITIONAL INFORMATION BECOMES 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 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. THE DEVICE WAS THEN SUBJECTED TO, AND PASSED, A SERIES OF DIAGNOSTIC TESTS TO ASSESS THE PERFORMANCE OF DEFIBRILLATION, PACING, SENSING, HIGH VOLTAGE SHOCKING, AND DIAGNOSTIC RECORDING FUNCTIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DECLARED A BATTERY STATUS OF ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CHARGE TIMES OUTSIDE OF THE CHARGE TIME LIMIT. THE DEVICE IS SCHEDULED TO BE REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS. AS OF TODAY, AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATED THAT THIS DEVICE WAS EXPLANTED. THE DEVICE HAS BEEN 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 T175

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention T175| 0158