BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2040773 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00836
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    June 1, 2010
    Report Date
    January 11, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THIS PG REMAINS IMPLANTED NO ANALYSIS WILL BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT IMPLANTED WITH THIS PULSE GENERATOR (PG) EXPERIENCES A PLEURAL EFFUSION AND SHORTNESS OF BREATH. THIS PATIENT WAS HOSPITALIZED AND THE FLUID WAS DRAINED. THIS PG REMAINS IMPLANTED.

    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 78 YR 4096| (B)(4)| 4097