BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM 2

    MDR report key: 2914346 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00827
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 27, 2012
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 DEVICE WAS UNABLE TO BE INTERROGATED, NOR COULD A MAGNET RATE BE OBTAINED. AS A RESULT THE DEVICE WAS EXPLANTED AND UPGRADED DEVICE WAS SUCCESSFULLY IMPLANTED WITHOUT INCIDENT. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19710 VENTAK PRIZM 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CLONMEL IRELAND 1861

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R 1488T| 1861| 0147