BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSIGNIA

    MDR report key: 2133450 · Received June 20, 2011

    Report

    Report Number
    2124215-2011-10568
    Event Type
    Death
    Date Received
    June 20, 2011
    Date of Event
    January 31, 2011
    Report Date
    May 25, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS OBTAINED FROM THE FIELD REPRESENTATIVE THAT THE (B)(6) WAS NOT DUE TO THE DEVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT EXPIRED DUE TO A (B)(6) ALONG WITH MULTIPLE SYSTEM FAILURE. THE DEVICE WAS EXPLANTED AT THE MORTUARY. NO PERFORMANCE ISSUES WERE REPORTED AGAINST THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death 1297| 4053| 4034