BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1952706 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23615
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    October 29, 2010
    Report Date
    December 3, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    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 RECEIVED INFORMATION THAT THIS DEVICE SYSTEM WAS EXPLANTED DUE TO PATIENT INFECTION. A NEW SYSTEM WAS LATER IMPLANTED WITHOUT COMPLICATION. NO FURTHER OBSERVATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S203

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R S203| 4135| 4136