BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3212928 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10239
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 3, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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 CHARGE TIMES GREATER THAN THE CHARGE TIME LIMIT. END OF LIFE (EOL) WAS DECLARED FOLLOWING A SINGLE CHARGE TIME GREATER THAN 30 SECONDS. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE AND THE RESULTS INDICATED THE MONITORING VOLTAGE WAS NORMAL BASED ON THERAPY USE AND PROGRAMMED SETTINGS. IT WAS CONCLUDED THAT THIS DEVICE DID NOT EXPERIENCE PREMATURE BATTERY DEPLETION. RATHER, THE ERI TO EOL TIME PERIOD WAS SHORTENED DUE TO A HIGHER-THAN-TYPICAL BUILDUP OF INTERNAL BATTERY IMPEDANCE. THE DEVICE WAS CAPABLE OF DETECTING AND TREATING ARRHYTHMIAS, AS THE BATTERY ITSELF HAD SUFFICIENT CAPACITY REMAINING TO PROVIDE THERAPY IF NEEDED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS AT END OF LIFE (EOL) AND HAD A FAULT CODE THAT INDICATED A CHARGE TIMEOUT, BATTERY VOLTAGE WAS 2.6 VOLTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THE CHARGE TIMEOUT INDICATED THAT THE CAPACITORS WERE NOT CHARGED TO THE PROGRAMMED VOLTAGE WITHIN 45 SECONDS AFTER CHARGING. THE SHOCK WAS FOR AN ATRIAL ARRHYTHMIA WITH A RAPID VENTRICULAR RESPONSE, AND NOT A VENTRICULAR ARRHYTHMIA. THE PATIENT HAD PNEUMONIA AND WAS ADMITTED TO THE HOSPITAL UNTIL THE CHANGE-OUT OCCURED, AND THE ATRIAL ARRHYTHMIA WAS BEING CONTROLLED WITH MEDICATIONS. SUBSEQUENT INFORMATION WAS RECEIVED THAT THE ICD WAS SUCCESSFULLY REPLACED WITH NO ADDITIONAL ADVERSE PATIENT EFFECTS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311959 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 4469| T165| 0184