BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3902098 · Received May 6, 2014

    Report

    Report Number
    2916596-2014-00714
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON GOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. A PORTION OF THE PERCUTANEOUS LEAD THAT WAS REMOVED DURING THE REPAIR WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE CIRCULATORY SUPPORT SPECIALIST COORDINATOR THAT THE PT HAD EXTREMELY TWISTED UP THE PERCUTANEOUS LEAD (LEAD) AND PUMP STOPPAGE WAS NOTED IN THE LOG FILE. THE PT WAS ADMITTED FOR OBSERVATION AND THE LEAD WAS UNTWISTED. THE FOLLOWING DAY, THE MFR'S TECHNICAL SERVICES REPRESENTATIVE CONDUCTED A PERCUTANEOUS LEAD EVAL WHICH DID NOT REPRODUCE ANY SPEED REDUCTIONS OR PUMP STOPPAGE AND FOUND ALL LEAD CONDUCTORS TO PASS THE CONTINUITY TESTING. THE SYSTEM CONTROLLER WAS EXCHANGED WITH ANOTHER SYSTEM CONTROLLER. X-RAY OF THE EXTERNAL SECTION OF THE LEAD WAS FOUND TO BE UNREMARKABLE. IT WAS REPORTED ON (B)(6) 2014 THAT THE PT'S DRIVELINE HAS BEEN NICKED DURING A PRIOR ABDOMINAL SURGERY WHICH MAY BE CAUSING THE DRIVELINE FAULT ALARMS. ON (B)(6) 2014 AN EXTERNAL PERCUTANEOUS LEAD REPLACEMENT WAS PERFORMED BY THE MFR'S TECHNICAL SERVICES REPRESENTATIVE ACCORDING TO PROCEDURE. THREE DAYS LATER, THE PT WAS READMITTED FOR REPORTED DRIVELINE FAULT AND PUMP STOPPAGE EVENTS. THE PT IS BEING CONSIDERED FOR A PUMP EXCHANGE. THE PT HAS NOT SUFFERED ANY SIDE EFFECTS FROM THE REPORTED DRIVELINE FAULT OR PUMP STOPPAGE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271374 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 102431

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention (B)(4)| (B)(4)| (B)(4)| HEARTMATE II SYSTEM CONTROLLER, SERIAL NUMBERS: (B)(4)