BEUDAMED
    FDA Adverse Event Death Summary report: N

    ITREVIA 5 HF-T QP DF4 IS4 PROMRI

    MDR report key: 6196029 · Received December 21, 2016

    Report

    Report Number
    1028232-2016-05037
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    October 8, 2016
    Report Date
    December 7, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NIK
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. CONCLUSIONS REGARDING THE CLINICAL OBSERVATION CANNOT BE MADE FOR THE TIME BEING. THE INVESTIGATION WILL BE CONTINUED AS SOON AS NEW INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6). RESUSCITATION MEASURES WERE ATTEMPTED. VENTRICULAR FIBRILLATION IS CONSIDERED A POSSIBLE CAUSE OF DEATH. BIOTRONIK HAS, SO FAR, NOT RECEIVED ANY ADDITIONAL INFORMATION ON THE CAUSE OF DEATH. THE DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846634 ITREVIA 5 HF-T QP DF4 IS4 PROMRI CRT-D NIK BIOTRONIK SE & CO. KG 402657

    Patients

    Seq Age Sex Outcome Treatment
    1 Death