BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 2163541 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07675
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    June 26, 2009
    Report Date
    April 22, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. 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) WAS PART OF A SYSTEM EXPLANT. AN ALLEGATION FROM THE PATIENT ADVOCATE REPORTED THAT THE DEVICE WAS NOT READING PROPERLY. DURING THIS PROCEDURE TWO OTHER BOSTON SCIENTIFIC LEADS WERE REMOVED. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T127

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R 0155| 1861| T127| 6947| MISMATCH| 4194| 4087