BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1852110 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14655
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 12, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPLACED WITH A PACEMAKER DUE TO THE PATIENT'S OTHER MEDICAL CONDITIONS. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS STARTING TO ERODE THROUGH THE PATIENT'S SKIN. IT WAS NOTED THAT THE PATIENT HAD BECOME EXTREMELY THIN. THE ICD HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) BATTERY STATUS AND WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention T175| S601| 0185