BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23888318 · Received December 24, 2025

    Report

    Report Number
    1220648-2025-49273
    Event Type
    Injury
    Date Received
    December 24, 2025
    Date of Event
    September 22, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY VENTRICULAR TACHYCARDIA: 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. DEVICE HISTORY LOT DEVICE LOT : 1972075 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 THAT AN IMPELLA CP PUMP WAS IMPLANTED TO SUPPORT A PATIENT WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK. ON THE MORNING OF THE PROCEDURE, THE PATIENT EXPERIENCED RUNS OF VENTRICULAR TACHYCARDIA. NO ECHOCARDIOGRAM HAD BEEN PERFORMED AT THE TIME. THE IMPELLA CP WAS INSERTED VIA THE LEFT FEMORAL ARTERY (LFA) WITHOUT COMPLICATION. THE PATIENT WAS SUCCESSFULLY WEANED FROM IMPELLA SUPPORT, AND THE DEVICE WAS EXPLANTED WITHOUT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2453236 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026722079 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention