BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2503195 · Received March 20, 2012

    Report

    Report Number
    2916596-2012-00233
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Date of Event
    February 20, 2012
    Report Date
    February 20, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S TECHNICAL SERVICES TEAM MEMBER EVALUATED THE PATIENT'S LEAD AND CONFIRMED DAMAGE CONSISTENT WITH CUTTING WITH SCISSORS. AFTER CONSULTING WITH THE HOSPITAL, A SECOND REPLACEMENT OF THE DISTAL END OF THE LEAD WAS SUCCESSFULLY PERFORMED. THE PATIENT REMAINS ONGOING ON LVAD SUPPORT WITH NO FURTHER ISSUE. A PORTION OF THE LEAD THAT WAS REMOVED AND RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT (B)(6) WEEKS FOLLOWING A PERCUTANEOUS LEAD (LEAD) DISTAL END REPLACEMENT BY THE MANUFACTURER'S TECHNICAL SERVICES TEAM MEMBER DUE TO MECHANICAL DAMAGE OF THE LEAD WITH SCISSORS (REFERENCE MEDWATCH REPORT # 0002916596-2012-00194), THE PATIENT WAS STILL EXPERIENCING "RED HEART" AND "LOW SPEED HAZARD" ALARMS. A REVIEW OF THE HISTORICAL LOG FILE DATA REVEALED ABNORMAL SPEED DROPS AND PUMP STOPPAGE EVENTS RECORDED. THE ALARMS WERE REPORTEDLY REPRODUCIBLE WITH MANIPULATION OF THE LEAD AND VISUAL INSPECTION OF THE LEAD REVEALED SIGNS OF EXTERNAL DAMAGE CONSISTENT WITH INTENTIONAL CUTTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 100755

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention