BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIFY ASSURA ICD

    MDR report key: 6355498 · Received February 23, 2017

    Report

    Report Number
    2938836-2017-16214
    Event Type
    Death
    Date Received
    February 23, 2017
    Date of Event
    February 11, 2017
    Report Date
    February 14, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE PATIENT EXPIRED DUE TO VENTRICULAR FIBRILLATION. IT IS UNKNOWN IF THE DEVICE DELIVERED THE CORRECT CORRESPONDING THERAPY. ADDITIONAL INFORMATION IS NOT YET AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT EXPIRED AT HOME DUE TO A VENTRICULAR FIBRILLATION STORM. THE DEVICE CORRECTLY DELIVERED ATP AND CEI THERAPY; HOWEVER, SEVERAL THERAPIES WERE ABORTED WHEN THE PATIENT WAS STILL EXPERIENCING ARRHYTHMIA. THE MERLIN@HOME REMOTE CARE UNIT WAS FOUND NEAR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135557 UNIFY ASSURA ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC. CD3361-40QC 4712565

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death