BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA

    MDR report key: 12359685 · Received August 23, 2021

    Report

    Report Number
    MW5103455
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    August 18, 2021
    Report Date
    August 19, 2021
    Manufacturer
    ABIOMED INC.
    Product Code
    OJE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IMPELLA DEVICE PLACED ON (B)(6) 2021. ON (B)(6), IMPELLA SIGNAL HAVING NEGATIVE SPIKES. ON (B)(6)IMPELLA NOT FUNCTIONING NO WAVEFORM ON R SIDED IMPELLA, PROVIDER SPOKE WITH MANUFACTURER. POSSIBLE THROMBUS/CLOTS. DEVICE REMOVED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251958 IMPELLA RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE OJE ABIOMED INC. 004334 307956

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR