BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 23750844 · Received December 8, 2025

    Report

    Report Number
    1220648-2025-48837
    Event Type
    Death
    Date Received
    December 8, 2025
    Date of Event
    November 9, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 HEALTH EFFECT - CLINICAL CODE 060110 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT . THE INVESTIGATION OF THE REPORTED FAILURE MODE HAS BEEN COMPLETED. NO PRODUCT WAS RECEIVED FOR EVALUATION. VENTRICULAR FIBRILLATION: THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. FEVER: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY REVIEW: THE DEVICE PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT IN CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE PATIENT WAS HAVING RUNS OF VENTRICULAR TACHYCARDIA THROUGH THE NIGHT. STARTED THE PATIENT ON LIDOCAINE. THE PATIENT HAD A SLIGHT FEVER. IT WAS ALSO REPORTED THAT THE PATIENT EXPIRED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2678719 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026708164 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Death