BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2170275 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10106
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    March 8, 2011
    Report Date
    May 31, 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

    AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED AN INCREASED CHARGE TIME (CT) OF 18.4 SECONDS, WHICH WAS QUESTIONED. IT WAS NOTED THAT SEVERAL MANUAL CAPACITOR REFORMATIONS (MCR'S) WERE DONE WHICH RESULTED IN DECREASED CT OF 16 SECONDS. TECHNICAL SERVICES (TS) DISCUSSED ELECTIVE REPLACEMENT INDICATOR (ERI) INDICATORS BASED ON BATTERY VOLTAGE AND CT. THIS PATIENT WOULD CONTINUE TO BE MONITORED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE DEVICE REACHED ERI AND THEN END OF LIFE (EOL) IN LESS THAN 3 MONTHS. THE DEVICE WAS SUBSEQUENTLY EXPLANTED DUE TO NORMAL BATTERY DEPLETION. 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 T135

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention T135| 0158