BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSIGNIA

    MDR report key: 2162500 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07302
    Event Type
    Death
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    August 30, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS DEVICE HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    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

    FURTHER INFORMATION WAS LATER RECEIVED THAT THE PATIENT HAD DIED PRIOR TO A PROCEDURE SCHEDULED TO IMPLANT A NEW SYSTEM. IT WAS REPORTED THE PATIENT WAS VERY SEPTIC.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER WAS EXPLANTED DUE TO AN INFECTION.

    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 56 YR Death 1283| 5068| 4137| 5076| 1291