BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 6324434 · Received February 10, 2017

    Report

    Report Number
    2938836-2017-14546
    Event Type
    Death
    Date Received
    February 10, 2017
    Date of Event
    January 10, 2017
    Report Date
    January 16, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. PATIENT WAS HOSPITALIZED FROM (B)(6) 202016 FOR INCREASED SHORTNESS OF BREATH. DURING THE COURSE OF THE STAY, HIS DIAGNOSIS WAS ACUTE DECOMPENSATION OF CHRONIC CONGESTIVE HEART FAILURE, COMBINED SYSTOLIC AND DIASTOLIC HEART FAILURE WITH A NYHA CLASS IV WHICH IMPROVED TO III, DILATED CARDIOMYOPATHY, ATRIAL FIBRILLATION, AND STAGE 3 CHRONIC KIDNEY DISEASES. THE PATIENT WAS FOUND TO BE PROFOUNDLY HYPOTENSIVE AND IN PRE-CARDIOGENIC SHOCK. PATIENT¿S CONDITION WAS IMPROVED WITH TREATMENT AND DISCHARGED HOME ON (B)(6) 2016. THE PATIENT WAS ADMITTED TO HOSPICE CARE ON (B)(6) 2016 WITH A LIFE EXPECTANCY OF LESS THAN 6 MONTHS IF THE TERMINAL ILLNESS RAN ITS COURSE. THE PATIENT WAS SEEN IN THE CLINIC FOR FOLLOW-UP DEVICE CHECK ON (B)(6) 2016. PATIENT HAD BEEN DOING FAIRLY WELL SINCE THE HOSPITALIZATION. PATIENT HAD MODERATE BASELINE SHORTNESS OF BREATH BUT WAS DOING WELL OTHERWISE FROM A CARDIAC STANDPOINT. THE DEVICE WAS FOUND TO BE FUNCTIONING NORMALLY AT THAT TIME. DURING THE COURSE OF HOSPICE CARE, BEGINNING ON (B)(6) 2016, THE PATIENT¿S HEALTH DECLINED AS THE TERMINAL ILLNESS PROGRESSED. THE PATIENT EXPIRED AT HOME ON (B)(6) 2017 WITH THE CAUSE OF DEATH BEING COMPLICATIONS FROM CONGESTIVE HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104037 QUICKFLEX MICRO LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1258T/86 3502628

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death (B)(4)| (B)(4)| (B)(4)