BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 2052618 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03485
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    January 3, 2011
    Report Date
    March 2, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, EOL WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE. THIS DEVICE IS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ((B)(4) 2007) ADVISORY POPULATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED END OF LIFE (EOL) APPROXIMATELY SEVEN MONTHS AGO. IT WAS NOTED THAT THE PATIENT HAD MULTIPLE EVENTS APPROXIMATELY THREE TO FOUR MONTHS AGO. THE DEVICE RECORDED A DIVERTED EPISODE AS WELL AS A SHOCK DELIVERED. THE MARKERS FOR THESE EVENTS WERE QUESTIONED. TECHNICAL SERVICES (TS) DISCUSSED THE MARKERS AND THAT IT WAS NORMAL DEVICE OPERATION. THERE WERE NO DEVICE ALLEGATIONS AT THAT TIME. THE DEVICE WAS LATER EXPLANTED DUE TO ELECTIVE REASONS AND WAS RETURNED FOR ANALYSIS. ROUTINE INITIAL DEVICE TESTING INDICATED THAT DETAILED ANALYSIS WAS REQUIRED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T127

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 6949| 4470| T127