BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM

    MDR report key: 1944864 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19421
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    November 1, 2000
    Report Date
    October 1, 2010
    Manufacturer
    CPI PLANT - ST. PAUL
    Product Code
    LWS
    Removal / Correction Number
    Z-613/618-1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ALLEGATION AGAINST DEVICE FUNCTIONALITY AND DUE TO THIS, ANALYSIS IS NOT REQUIRED. THE SYSTEM WAS EXPLANTED DUE TO PATIENT INFECTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS DEVICE REPORTED THAT THE DEVICE AND LEADS WERE EXPLANTED, DUE TO INFECTION APPROXIMATELY LESS THAN ONE MONTH FOLLOWING IMPLANT. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CPI PLANT - ST. PAUL 1851

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R 0145| 1851| 4244