BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INOGEN X4 CRT-D

    MDR report key: 9945389 · Received April 9, 2020

    Report

    Report Number
    2124215-2020-05893
    Event Type
    Injury
    Date Received
    April 9, 2020
    Date of Event
    February 3, 2020
    Report Date
    April 9, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    UDI-DI
    00802526534591
    PMA / PMN Number
    P010012/S341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    03/22/2020 - THIS DEVICE WAS EXPLANTED DUE TO AN INFECTION. NO ADDITIONAL ADVERSE SERIOUS INJURY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410568 INOGEN X4 CRT-D IMPLANTABLE DEFIBRILLATOR NIK BOSTON SCIENTIFIC CORPORATION G148 221317 00802526534591

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R