BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSIGNIA

    MDR report key: 3973353 · Received August 1, 2014

    Report

    Report Number
    2124215-2014-14902
    Event Type
    Death
    Date Received
    August 1, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 14, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE PATIENT WITH THIS DEVICE WAS SEEN FOR A ROUTINE FOLLOW-UP, AT WHICH TIME THE DEVICE WAS CONFIRMED IN END OF LIFE (EOL); TIME STAMPED OVER FIVE MONTHS PRIOR. REPORTEDLY, THE PATIENT HAD NOT BEEN SEEN CLINICALLY FOR OVER TWO YEARS. A REPLACEMENT PROCEDURE WAS SCHEDULED FOR THE FOLLOWING WEEK; HOWEVER TWO DAYS PRIOR TO THE SCHEDULED REPLACEMENT, THE PATIENT RETURNED WITH A DROP IN PRESSURE AND LOSS OF BRADY PACING. MEDICAL INTERVENTION WAS PERFORMED HOWEVER, THE PATIENT PASSED AWAY. NO RETURN OF PRODUCT IS EXPECTED AND NO FURTHER INFORMATION HAS BEEN OBTAINABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450651 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1292

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R 4095| 1292| 4459