BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOGEN

    MDR report key: 6076399 · Received November 3, 2016

    Report

    Report Number
    2124215-2016-18395
    Event Type
    Death
    Date Received
    November 3, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 18, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    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

    BOSTON SCIENTIFIC RECEIVED A CALL FROM THE PATIENT'S SON REPORTING THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM PASSED AWAY THREE DAYS POST-IMPLANT. THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE WAS CONTACTED AND WAS NOT AWARE THAT THE PATIENT HAD DIED, BUT CONFIRMED THAT SHE WOULD FOLLOW-UP WITH THE PHYSICIAN FOR ADDITIONAL INFORMATION ABOUT WHAT OCCURRED FOLLOWING THE PROCEDURE UP UNTIL THE PATIENT PASSED AWAY. ACCORDING TO THE IMPLANT RECORD, NO DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED. THE DEVICE WAS NOT RETURNED. THE LOCAL FIELD REPRESENTATIVE SPOKE WITH THE CLINIC NURSE WHO INFORMED THAT SHE DID NOT KNOW WHY THE PATIENT DIED; ALL SHE KNEW WAS THERE WERE ALLEGATIONS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727832 INOGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND D142

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death 0296| 4470| D142