BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTAK PRIZM VR HE IS-1/DF-1 VVIR

    MDR report key: 1703348 · Received May 21, 2010

    Report

    Report Number
    2124215-2010-10338
    Event Type
    Death
    Date Received
    May 21, 2010
    Date of Event
    May 4, 2010
    Report Date
    March 31, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION ON (B)(6) 2010. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE. BOSTON SCIENTIFIC RECEIVED INFORMATION IN LATE-(B)(6) 2016 THAT THIS PATIENT HAD DIED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM VR HE IS-1/DF-1 VVIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND 1852 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death| H| L| R