BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSIGNIA

    MDR report key: 2171657 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-12171
    Event Type
    Death
    Date Received
    July 21, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD. 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 SPOUSE CALLED TO REPORT THAT THIS PATIENT HAD DIED AND THAT THE DEVICE "DIDN'T WORK'. THE SPOUSE COMMENTED THAT SHE WAS INFORMED BY AN ATTORNEY THAT THIS DEVICE HAD BEEN RECALLED. THE SPOUSE WAS INFORMED THAT THE DEVICE WAS NOT INCLUDED IN ANY ADVISORIES OR RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death 4086| 1290| 4087