BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP

    MDR report key: 12484492 · Received September 16, 2021

    Report

    Report Number
    2916596-2021-05074
    Event Type
    Injury
    Date Received
    September 16, 2021
    Date of Event
    October 1, 2019
    Report Date
    September 30, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS ORIGINALLY REPORTED UNDER MFR# 2916596-2022-02063 AS PART OF A HISTORICAL JMACS PATIENT REGISTRY REVIEW IN JAPAN THROUGH MCS ABBOTT JAPAN AFFILIATE. ON 26SEP2022 THE REVIEW OF FILES OF THIS EVENT TYPE WAS COMPLETED. THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. INFECTION IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. INFECTION HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED A BACTERIAL DRIVELINE INFECTION. THEY WERE READMITTED TO THE HOSPITAL ON (B)(6) 2019. IV ANTIBIOTICS WERE GIVEN. THE PATIENT WAS DISCHARGED ON (B)(6) 2019. THE PATIENT WAS LATER READMITTED ON (B)(6) 2019. THEY WERE GIVEN IV ANTIBIOTICS. THE PATIENT WAS DISCHARGED ON (B)(6) 2019.

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. INFECTION IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. INFECTION HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS.  NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A DRIVELINE INFECTION IN UPPER UMBILICAL SITE. THE TYPE OF INFECTION WAS MRSA. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382528 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 104911JPN 6450778

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Hospitalization| R