BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALTRUA

    MDR report key: 5445559 · Received February 18, 2016

    Report

    Report Number
    2124215-2016-02926
    Event Type
    Death
    Date Received
    February 18, 2016
    Date of Event
    January 27, 2016
    Report Date
    January 27, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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 INFORMATION THAT DURING ROUTINE REPLACEMENT OF THIS PACEMAKER ON (B)(6) 2016, AFTER PROPOFOL WAS ADMINISTERED, THE PATIENT WAS FOUND TO BE UNRESPONSIVE AND HAD NO PULSE. THE PATIENT WAS REVIVED WITH CARDIOPULMONARY RESUSCITATION (CPR) AND WAS INTUBATED. A DEVICE CHECK PRIOR TO THE PROCEDURE NOTED APPROPRIATE DEVICE FUNCTION AND ALSO NOTED THE PATIENT WAS IN ATRIAL FIBRILLATION (AF). AFTER CPR, THE PATIENT WAS STILL NOTED TO BE AF WITH CONSISTENT R-WAVES AND ACCEPTABLE THRESHOLD MEASUREMENTS. AN ADDITIONAL DEVICE CHECK NOTED APPROPRIATE DEVICE FUNCTION. THE PATIENT THEN HAD ANOTHER EPISODE AND CPR WAS AGAIN PERFORMED AND THE PATIENT RECOVERED AND WAS ADMITTED TO THE INTENSIVE CARE UNIT. IT WAS SUSPECTED THAT THE PATIENT HAD A REACTION TO THE ADMINISTERED MEDICATIONS. DEVICE REPLACEMENT WAS CANCELLED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT DIED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100664 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| H| L| R