BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - WAIST PACK

    MDR report key: 23064359 · Received September 16, 2025

    Report

    Report Number
    3007042319-2025-02032
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    September 11, 2025
    Report Date
    October 5, 2025
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707008082
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ANALYSIS AND INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: THE WAIST PACK (LOT NO. 0010068) WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. VISUAL EVIDENCE PROVIDED BY THE SITE REVEALED THAT THE SEAMS AROUND THE CONTROLLER POCKET WERE DAMAGED. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED, BUT NOT LIMITED, TO WEAR AND/OR THE HANDLING OF THE PACK. CAPA PR00519581 WAS CREATED TO INVESTIGATE DAMAGED PACKS. INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. 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 WAIST PACK WAS RIPPED. THE WAIST PACK WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2679912 HEARTWARE VENTRICULAR ASSIST SYSTEM - WAIST PACK VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 2050 0010068 00888707008082

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MCS UNKNOWN VAD.