BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 18664261 · Received February 7, 2024

    Report

    Report Number
    2916596-2024-00859
    Event Type
    Malfunction
    Date Received
    February 7, 2024
    Date of Event
    February 5, 2024
    Report Date
    February 20, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS DETERMINED TO BE SUPPLEMENTAL INFORMATION. THE INVESTIGATION FINDINGS WILL BE SUBMITTED UNDER MDR-2023-49816-01.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S DRIVELINE WAS RESCUE TAPED. A CLAMSHELL REPAIR WAS PERFORMED FOR (B)(6) 2024 WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1906874 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106015 5925520 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention