BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2060039 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05839
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 20, 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

    ADDITIONAL INFORMATION RECEIVED INDICATED THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THE REPLACEMENT PROCEDURE. AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, CRM FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF FURTHER INFORMATION BECOMES AVAILABLE THIS EVENT WILL BE REOPENED.

    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

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN MADE. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WHICH WAS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS PRODUCT UPDATE CLASSIFIED AS A PRODUCT ADVISORY WAS INITIALLY COMMUNICATED ON (B)(6) 2007, DECLARED END OF LIFE (EOL) DUE TO A CHARGE TIME MEASUREMENT GREATER THAN 30 SECONDS. THE MONITORING VOLTAGE WAS 2.68 VOLTS. ADDITIONALLY, IT WAS REPORTED THAT ELECTIVE REPLACEMENT INDICATOR (ERI) HAD BEEN DECLARED APPROXIMATELY ONE MONTH PRIOR. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT RECOMMENDED REPLACING THE ICD. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 0185| T177