BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 23181605 · Received September 30, 2025

    Report

    Report Number
    1220648-2025-47026
    Event Type
    Death
    Date Received
    September 30, 2025
    Date of Event
    August 31, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4 IS UNKNOWN. THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO PRODUCT WAS RETURNED FOR INVESTIGATION. TACHYCARDIA: IN ORDER TO MAKE A ROOT CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN (B)(4) WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE TACHYCARDIA WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT : DEVICE LOT: 1963644, DEVICE HISTORY BATCH : SUBCOMPONENT LOT: N/A, DEVICE HISTORY REVIEW : DEVICE WITH SN: (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA CP EXPERIENCED MULTIPLE EPISODES OF SUSTAINED VENTRICULAR TACHYCARDIA. THE PATIENT WAS DEFIBRILLATED AND TREATED WITH DOBUTAMINE, AMIO, AND PRESSORS. LATER, CARE WAS WITHDRAWN AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587034 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026725410

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Death