BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 23521150 · Received November 11, 2025

    Report

    Report Number
    1220648-2025-48254
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    October 14, 2025
    Report Date
    December 31, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: 1932234. DEVICE HISTORY BATCH: SUBCOMPONENT LOT: N/A. DEVICE HISTORY REVIEW: DEVICE WITH SN: 603340 PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING IMPELLA 5.5 SUPPORT, THE PATIENT WAS MOVED OUT OF BED TO A CHAIR BUT HAD SUSTAINED VENTRICULAR TACHYCARDIA. LEVOPHED WAS INCREASED AND THE PATIENT WAS TAKEN BACK TO BED. THE PATIENT LIKELY WILL NEED A LONGER DURATION OF IMPELLA 5.5 SUPPORT PER THE MEDICAL DOCTOR. ADDITIONAL INFORMATION WAS RECEIVED FROM THE AREA CLINICAL CONSULTANT. THE DEVICE IS NOT AVAILABLE FOR RETURN AND THE VENTRICULAR TACHYCARDIA HAD NOTHING TO DO WITH THE IMPELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877559 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2026692751 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention