BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE STROKE VOLUME LIMITER

    MDR report key: 467026 · Received June 20, 2003

    Report

    Report Number
    2916596-2003-00050
    Event Type
    Injury
    Date Received
    June 20, 2003
    Report Date
    May 23, 2003
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A VENTED ELECTRIC LVAD IN 2002. IN 05/2003, THE HOSPITAL TRANSPLANT COORDINATOR REPORTED TO THE MANUFACTURER THAT A PATIENT ON A VENTED ELECTRIC LVAD, WHO WAS ON PNEUMATIC BACK UP OPERATING MODE UTILIZING A DRIVE CONSOLE AND STROKE VOLUME LIMITER (SVL) BROKE THE SVL. THE PATIENT WAS LYING IN BED AND ROLLED OVER WHEN THE PATIENT SIDE TUBING ON THE SVL HAD BROKEN OFF. THE PATIENT NOTIFIED NURSING PERSONNEL AND THE SVL WAS CHANGED TO A BACK UP SVL, AND THERE WAS NO INJURY TO PATIENT. THE PATIENT RECIEVED A HEART TRANSPLANT IN 05/2003, AND IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE STROKE VOLUME LIMITER STROKE VOLUME LIMITER DSQ THORATEC CORP. 1295 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention