BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 25316665 · Received May 28, 2026

    Report

    Report Number
    3007042319-2026-00916
    Event Type
    Death
    Date Received
    May 28, 2026
    Date of Event
    May 17, 2026
    Report Date
    May 28, 2026
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707002493
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) PATIENT WITH A HISTORY OF CARDIOMYOPATHY EXPERIENCED A CHRONIC LONG-STANDING CONDITION AND WAS ADMITTED TO A LOCAL HOSPITAL. WHILE HOSPITALIZED, THE PATIENT PASSED AWAY DUE TO "OLD AGE AND A LONG STANDING CHRONIC CONDITION" AND THE TERMINAL STATE WAS NOTED TO BE UNRELATED TO ANY ISSUES WITH THE VAD; HOWEVER, AN OFFICIAL CAUSE OF DEATH NOR THE SPECIFIC CHRONIC CONDITION WAS MADE AVAILABLE. REVIEW OF LOG FILES DEMONSTRATED THAT THE PUMP WAS NOT RUNNING WHICH CORRELATES WITH THE DATE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163794 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1104 00888707002493

    Patients

    Seq Age Sex Outcome Treatment
    1