BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TLC-II DRIVER

    MDR report key: 8655113 · Received May 30, 2019

    Report

    Report Number
    2916596-2019-02457
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    May 14, 2019
    Report Date
    August 5, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UDI NUMBER - (B)(4). MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT, OF THE DDC (B)(4) HAVING FLUCTUATING DRIVE PRESSURE ISSUES, WAS CONFIRMED. THE UNIT WAS SERVICED AT THE CUSTOMER¿S SITE BY TECHNICAL SERVICE. THE TOP MODULE WAS REPLACED. THE REPLACEMENT TOP MODULE CAME FROM ONE OF THE CUSTOMER¿S OTHER DDC (B)(4). THE PATIENT HAD BEEN SWITCHED OVER TO THE DDC CONSOLE PENDING ARRIVAL OF REPLACEMENT TLC-II DRIVERS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 1 YEAR 7 MONTHS (THE AGE IS CALCULATED FROM THE DATE OF IMPLANT TO THE EVENT DATE.). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH BIVENTRICULAR PARACORPOREAL VENTRICULAR ASSIST DEVICES (BIVAD PVAD) ON (B)(6) 2017. IT WAS REPORTED THAT A BIVAD PVAD PATIENT'S PORTABLE DRIVER WAS ALARMING ALL THE TIME. PER CUSTOMER, THE DDC DRIVER STARTED ALARMING DEAD BATTERY AS SOON AS UNPLUGGED. DDC-729 WILL BE USED AS A BACKUP TO THE TLC-II CONSOLES AND REMAINED PLUGGED INTO A RED POWER OUTLET. CUSTOMER REQUESTED SERVICE ON THE DDC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446825 TLC-II DRIVER DUAL DRIVER DSQ THORATEC CORPORATION 20010-0000-081

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR