BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 3790197 · Received May 5, 2014

    Report

    Report Number
    2124215-2014-06048
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    February 24, 2014
    Report Date
    June 4, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    KRG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. DURING INITIAL INVESTIGATION, IT WAS REPORTED THAT THE DEVICE DID NOT HAVE AN ELECTIVE REPLACEMENT INDICATOR (ERI) TIMESTAMP AND THAT END OF LIFE (EOL) WAS DECLARED WHILE IMPLANTED. MEMORY ANALYSIS FOUND THAT EOL WAS DECLARED IN RESULT OF A LONG CHARGE TIME. THE CAUSE OF THE LONG CHARGE TIME WAS NOT DETERMINED. FURTHER DETAILED ANALYSIS FOUND NO FUNCTIONAL IRREGULARITIES IN DEVICE OPERATION. ALL THERAPY, SENSING, AND PACING WAS AVAILABLE AT THE TIME OF EXPLANT. LABORATORY ANALYSIS CONFIRMED THE REPORTED CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS SUSPECTED TO HAVE PREMATURE BATTERY DEPLETION (PBD). LAST ROUTINE FOLLOW UP IN JANUARY OF THIS YEAR SHOWED DEVICE LONGEVITY AT MIDDLE OF LIFE (MOL) STATUS. APPROXIMATELY ONE MONTH LATER, THE DEVICE EXHIBITED TONES AS THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). NORMAL MEASUREMENTS WERE OBSERVED ON THE ELECTRODES. DEVICE WAS THEN EXPLANTED AND WAS SENT FOR ANALYSIS. THIS ICD IS OUT OF SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266731 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR KRG GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R T177| 0175