BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 2041845 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01103
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 24, 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    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 BUILD-UP 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS BEING REPLACED DUE TO REACHING END OF LIFE (EOL). DURING THE REPLACEMENT, MULTIPLE EPISODES WERE NOTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE; ATTEMPT 1 WAS NOTED WITH 'NO THERAPY', ATTEMPT 2 HAD THERAPY DELIVERED. THESE EPISODES WERE QUESTIONED. TECHNICAL SERVICES RECOMMENDED A SAVE TO DISK, AND TO RETURN THE DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SAVE TO DISK WAS LATER RETURNED. ENGINEERING REVIEW OF THE SAVE TO DISK DATA REVEALED THAT THE ARRHYTHMIA LOGBOOK SHOWED THE DIVERTED SHOCKS FROM THE DAYS LEADING UP TO THE DEVICE REPLACEMENT WERE DUE TO CHARGE TIMEOUT FAULTS; FAULT CODE 01. THE EXPLANTED DEVICE WAS LATER RETURNED. ROUTINE INITIAL DEVICE TESTING INDICATED THAT DETAILED ANALYSIS WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T135

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR MISMATCH| E102| T135| 0145| 0040| 1850| 0041