BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 3915418 · Received June 5, 2014

    Report

    Report Number
    2916596-2014-00904
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 6, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S SYSTEM CONTROLLER (SERIAL #(B)(4)) WAS RETURNED TO THE MANUFACTURER AND FUNCTIONALLY TESTED. THE SYSTEM CONTROLLER WAS FOUND TO FUNCTION AS INTENDED DURING ANALYSIS EVEN WHILE SUPPORTED INDEPENDENTLY BY EITHER POWER LEAD. REVIEW OF THE PATIENT¿S EVENT HISTORY FROM THE RETURNED SYSTEM CONTROLLER CONFIRMED THE REPORTED EVENTS OF LOW FLOW, LOW SPEED OPERATION, AND PUMP STOPPAGES; HOWEVER, THE SUSPECTED DAMAGE TO THE PERCUTANEOUS LEAD COULD NOT BE CONFIRMED AS THE PUMP AND PERCUTANEOUS LEAD WERE NOT RETURNED FOR EVALUATION. THE PATIENT WAS GIVEN A NON-GROUNDED PATIENT CABLE AND REMAINED ON VAD SUPPORT WITH NO FURTHER EVENTS REPORTED UNTIL (B)(6) 2014 WHEN HE RECEIVED A ROUTINE TRANSPLANT. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS THAT WOULD AFFECT DEVICE FUNCTION OR PERFORMANCE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IMPLANTED AND IN USE BY THE PATIENT; HOWEVER, THE EXCHANGED SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROXIMATELY 17 MONTHS POST-IMPLANT, IT WAS REPORTED THAT THE PATIENT HEARD A SOUND FROM HIS PUMP FOR A SHORT MOMENT. THE PATIENT WENT TO THE HOSPITAL AND WAS READMITTED. THE VAD CARDIOLOGIST REVIEWED THE PATIENT'S EVENT HISTORY AND PUMP STOPPAGES, LOW SPEED AND LOW FLOW ALARMS WERE RECORDED. THE HOSPITAL TEAM REPLACED THE PATIENT'S SYSTEM CONTROLLER AND CONNECTED THE PATIENT TO BATTERY SUPPORT DUE TO SUSPECTED PERCUTANEOUS LEAD COMPROMISE. APPROXIMATELY 3 DAYS LATER, THE MANUFACTURER'S TECHNICAL SERVICE PERSONNEL INSPECTED THE PATIENT'S PERCUTANEOUS LEAD AND NO EXTERNAL DAMAGE WAS SEEN. THE HOSPITAL KEPT THE PATIENT ON A NON-GROUNDED CABLE AND WILL CONTINUE TO MONITOR THE PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT RECEIVED A ROUTINE TRANSPLANT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329429 HEARTMATE II LVAS, EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104912 113378

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other