BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 6058288 · Received October 26, 2016

    Report

    Report Number
    2649622-2016-13814
    Event Type
    Death
    Date Received
    October 26, 2016
    Date of Event
    September 2, 2016
    Report Date
    October 13, 2016
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: DDBB1D1 ICD, IMPLANTED: (B)(6) 2014. MW5064929. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED SEPSIS AND BECAME HYPOTENSIVE AS A RESULT. THE PATIENT WAS ADMITTED WITH CONCERN OF LEUKOCYTOSIS, WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND TRANSFERRED TO THE INTENSIVE CARE UNIT. "MUFFLED HEART TONES" WERE NOTED AND THE PATIENT EXPERIENCED RESPIRATORY DISTRESS. THE BLOOD CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS SEPTICEMIA, WHICH WAS COMPLICATED BY SEPTIC SHOCK. THE PATIENT DEVELOPED ACUTE RENAL FAILURE. THE PATIENT WAS TREATED FOR SEPTICEMIA AND BACTEREMIA. DUE TO PERSISTENT BACTEREMIA TRANS-ESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED AND THERE WAS CONCERN FOR "SECONDARY SEEDING" OF THE LEADS. THE PATIENT WENT TO THE OPERATING ROOM FOR REMOVAL OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS. THE LASER LEAD EXTRACTION WAS UNSUCCESSFUL AND COMPLICATED BY A FOUR CENTIMETER TEAR OF THE RIGHT ATRIUM AND SUPERIOR VENA CAVA (SVC), WHICH LEAD TO ACUTE PERICARDIAL TAMPONADE AND A NEED FOR EMERGENT STERNOTOMY. THE PATIENT LOST BLOOD PRESSURE AND A MASSIVE TRANSFUSION PROTOCOL WAS INITIATED. THE FAMILY WAS NOTIFIED AND ELECTED COMFORT CARE MEASURES. THE PATIENT IS DECEASED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNED THE RIGHT ATRIAL (RA) LEAD "REMOVED EASILY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708006 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death 407652 LEAD