BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIFY ASSURA CRT-D RF HV

    MDR report key: 10849731 · Received November 17, 2020

    Report

    Report Number
    2017865-2020-17678
    Event Type
    Death
    Date Received
    November 17, 2020
    Date of Event
    November 8, 2020
    Report Date
    November 16, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    UDI-DI
    05414734508216
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT PHYSICIAN NAME WAS PROVIDED - DR. (B)(6) AT (B)(6) MEDICAL CENTER. 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

    RELATED MANUFACTURER REPORT NUMBER: 2017865-2020-17679; 2017865-2020-17680; 2017865-2020-17681. IT WAS REPORTED THAT THE ATRIAL AND VENTRICULAR OUTPUTS WERE OBSERVED REMOTELY TO HAVE AN ALERT FOR HIGH OUTPUTS. SHORTLY THEREAFTER IT WAS LEARNED THAT THE PATIENT HAD PASSED AWAY. IT WAS QUESTIONED WHY AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SHOCK WAS NOT RECEIVED. REVIEW OF ONLINE ELECTROCARDIOGRAMS NOTED NON SUSTAINED ACTIVITY THAT LOOKED LIKE VENTRICULAR FIBRILLATION. FURTHER EVALUATION DETERMINED THE DEVICE HAD FUNCTIONED NORMALLY BUT THE VENTRICULAR FIBRILLATION WAS SO FINE THAT IT COULD NOT BE PROPERLY SENSED. ADDITIONAL INFORMATION SUGGESTS THE PATIENT MAY NOT HAVE RECEIVED A DEFIBRILLATION THRESHOLD TEST AT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315501 UNIFY ASSURA CRT-D RF HV IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3357-40Q A000079051 05414734508216

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death DURATA STS OPTIM ACTIVE.| QUICKFLEX LV LEAD.| TENDRIL STS.