BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALTRUA

    MDR report key: 3173368 · Received June 17, 2013

    Report

    Report Number
    2124215-2013-09575
    Event Type
    Death
    Date Received
    June 17, 2013
    Date of Event
    May 18, 2013
    Report Date
    June 7, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 FOLLOWING THE IMPLANT PROCEDURE, THE PATIENT WENT INTO RESPIRATORY DISTRESS AND CODED. CARDIOPULMONARY RESUSCITATION WAS PERFORMED AND THE PATIENT WAS INTUBATED. IT WAS SUSPECTED THAT THE PATIENT HAD A PULMONARY EDEMA. A PERICARDIAL CENTESIS WAS DONE AND THE PERICARDIAL EFFUSION DID NOT SHOW MUCH BLOOD PRESENT. THE FIELD REPRESENTATIVE CONFIRMED THE EVENTS WERE NOT DEVICE PRODUCT RELATED. SUBSEQUENTLY FIVE DAYS LATER, THE PATIENT EXPIRED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED FROM THE FIELD REPRESENTATIVE THAT THE PATIENT PRESENTED TO THE HOSPITAL PRIOR TO THE PROCEDURE IN SEVERE HEART FAILURE AND WAS SYMPTOMATIC DUE TO BRADYCARDIA. WHEN THE PROCEDURE STARTED, THE PATIENT'S BLOOD PRESSURE WAS VERY HIGH. WHEN THEY STARTED PACING, THE BLOOD PRESSURE STAYED ELEVATED CAUSING A LOT OF PRESSURE TO THE LUNGS WHICH CAUSED FLUID OVER LOAD. THE PATIENT WAS SUCCESSFULLY DISCHARGED TO THE TELEMETRY FLOOR FOLLOWING THE PROCEDURE, HOWEVER, THEIR KIDNEYS STARTED TO FAIL. AT THAT TIME THE FAMILY HAD ELECTED TO NOT DO ANYTHING AGGRESSIVE AND REQUESTED THE PATIENT BE PLACED IN HOSPICE CARE. THE PATIENT THEN SUBSEQUENTLY DIED FIVE DAYS LATER. ALTHOUGH THE PATIENT'S HEART FAILURE CONDITION WAS POOR PRIOR TO THE PROCEDURE, THE PHYSICIAN STILL FELT THE PROCEDURE MAY HAVE EXACERBATED THE CONDITION LEADING TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274028 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death 1888TC| S606