BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1944944 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19811
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE NATURE OF THE ISSUE, SHOULD THIS DEVICE GET RETURNED, ANALYSIS WOULD NOT BE REQUIRED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PACEMAKER WAS REMOVED FROM SERVICE ONE MONTH POST IMPLANT DUE TO SEVERE SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1291

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention 1291| 4137| 4136