BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23896392 · Received December 26, 2025

    Report

    Report Number
    1220648-2025-49319
    Event Type
    Injury
    Date Received
    December 26, 2025
    Date of Event
    September 28, 2025
    Report Date
    December 24, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY ==> CARDIAC ARREST/ ARRHYTHMIA: IN ORDER TO MAKE A CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN ES2023-0158 WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. RESPIRATORY FAILURE: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT ==> DEVICE LOT : 1960369. DEVICE HISTORY BATCH ==> SUB-COMPONENT LOT : N/A DEVICE HISTORY REVIEW ==> THE PUMP S/N: (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA CP FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT ENDURED A CARDIAC ARREST WITH HYPOXIA AND BRADYCARDIA. STAFF SUCCESSFULLY RESUSCITATED THE PATIENT AND TURNED THE CP UP TO P-9. THE PUMP WAS EVENTUALLY SUCCESSFULLY WEANED AND EXPLANTED, AND THE PATIENT SURVIVED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2403886 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026728048 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention