BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM 2

    MDR report key: 1864247 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16104
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    January 1, 2006
    Report Date
    August 9, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE PRODUCTS HAVE NOT BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND DEFIBRILLATION LEAD WERE EXPLANTED, DUE TO A PATIENT INFECTION. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1860

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention 1860| 0125| 1763