BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1874974 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18022
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    June 5, 2008
    Report Date
    September 16, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THIS PRODUCT HAS NOT BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INFORMATION INDICATES THAT THIS PRODUCT WAS DISPOSED AFTER EXPLANT BY THE HOSPITAL CATH LAB AS THERE WERE NO INDICATES OF A DEVICE MALFUNCTION OR PREMATURE BATTERY DEPLETION AT THAT TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PREVIOUSLY EXHIBITED EXTENDED CHARGE TIMES. THIS DEVICE WAS LISTED AS PART OF THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ADVISORY. IT WAS LATER REPORTED THAT THE PRODUCT WAS EXPLANTED FOR NORMAL BATTERY DEPLETION; HOWEVER, THE PATIENT HAD REQUESTED THE RETURN OF THE DEVICE FOR ANALYSIS DUE TO A POSSIBLE DEVICE MALFUNCTION. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Description of Event or Problem · 1

    --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention T165| 0185| 4470