BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERLIN HEART EXCOR DEVICE

    MDR report key: 6135036 · Received November 29, 2016

    Report

    Report Number
    MW5066380
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    November 23, 2016
    Report Date
    November 29, 2016
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    PCK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEFECT IN BERLIN HEART MACHINE, REQUIRING PATIENT TO UNDERGO SURGERY TO HAVE MACHINE SWAPPED OUT. DATES OF USE: (B)(6) 2016. REASON FOR USE: DILATED CARDIOMYOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784407 BERLIN HEART EXCOR DEVICE BERLIN HEART EXCOR DEVICE PCK BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention