BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE INC.

    MDR report key: 24505904 · Received March 4, 2026

    Report

    Report Number
    24505904
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    February 6, 2026
    Report Date
    February 12, 2026
    Manufacturer
    MEDTRONIC
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WITH HEARTWARE IMPLANT [REDACTED]. PATIENT PRESENTED WITH SHORTNESS OF BREATH AND LVAD [LEFT VENTRICULAR ASSIST DEVICE] RAMP STUDY WITH CONCERN FOR LVAD THROMBUS. ON EXAMINATION, THE LVAD PUMP HAD AN ABNORMAL GRINDING NOISE. LABS REVEALED A MARKED RISE IN LDH. IN ADDITION, DEVICE INTERROGATION REVEALS INCREASED POWER CONSUMPTION, WHICH WAS CONCERNING FOR LVAD PUMP THROMBOSIS. THROMBOLYTIC THERAPY WAS INITIATED X2, RESULTING IN IMPROVEMENT IN LVAD POWER PARAMETERS AND A MILD REDUCTION IN LDH, HOWEVER ABNORMAL PUMP SOUNDS PERSISTED AND LDH DID NOT NORMALIZE. AFTER DISCUSSION WITH THE MEDTRONIC ENGINEERING TEAM, THE FINDINGS WERE SUGGESTIVE OF RESIDUAL THROMBUS OR ROTOR IMBALANCE, EITHER OF WHICH WOULD BE BEST MANAGED WITH DEVICE EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574042 HEARTWARE INC. VENTRICULAR (ASSIST) BYPASS DSQ MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Other