BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2162510 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07113
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PACEMAKER WAS DISCARDED AT THE HOSPITAL, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIF FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT DEVELOPED A POCKET INFECTION. THE DECISION WAS MADE TO EXPLANT THIS PACEMAKER. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1194

    Patients

    Seq Age Sex Outcome Treatment
    1