BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 4810143 · Received June 2, 2015

    Report

    Report Number
    2916596-2015-00997
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 4, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE: 3 YEARS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE REPORTED LOW SPEED EVENTS AND PUMP STOPPAGES WERE CONFIRMED THROUGH THE EVALUATION OF THE SUBMITTED SYSTEM CONTROLLER LOG FILE. THE LOG FILES CAPTURED NUMEROUS TRANSIENT LOW SPEED EVENTS AND PUMP STOPPAGES, DURING WHICH LOW SPEED AND LOW FLOW HAZARD ALARMS WERE INTERMITTENTLY ACTIVE. IN ADDITION, THE EVENTS WERE ALSO ASSOCIATED WITH ELEVATIONS IN PUMP POWER UP TO 24.2 W AND AVERAGE PULSATILITY INDEX. ALL LOW SPEED EVENTS AND PUMP STOPPAGES CAPTURED IN THE SUBMITTED LOG FILE APPEARED TO OCCUR ONLY WHILE THE PATIENT WAS OPERATING ON THE POWER MODULE AND APPEARED CONSISTENT WITH A POTENTIAL PERCUTANEOUS LEAD WIRE COMPROMISE. FOUR X-RAYS OF THE INTERNAL AND EXTERNAL PORTIONS OF THE PATIENT'S PERCUTANEOUS LEAD (LEAD) WERE SUBMITTED FOR REVIEW. THE X-RAYS SHOWED AN AREA OF CONCERN ON THE INTERNAL PORTION OF THE LEAD SEVERAL INCHES FROM THE PUMP HOUSING WHERE THERE APPEARED TO BE POTENTIAL BREAKDOWN OF THE BRAIDED SHIELD. ANOTHER AREA OF POTENTIAL BREAKDOWN OF THE BRAIDED SHIELD COULD BE SEEN ON THE EXTERNAL PORTION OF THE LEAD IN THE APPROXIMATE LOCATION OF THE TERMINUS OF THE DISTAL END BEND RELIEF. HOWEVER, A POTENTIAL WIRE COMPROMISE COULD NOT BE DETERMINED VIA THE SUBMITTED X-RAY IMAGES. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ALARMS AFTER SWITCHING FROM BATTERIES TO AC POWER. THE SYSTEM CONTROLLER DATA LOG HISTORY CAPTURED LOW SPEED AND PUMP STOPPAGE EVENTS. A DAMAGED WIRE IN THE DRIVELINE WAS SUSPECTED. X-RAYS DID NOT SHOW A LOCATION WITH APPARENT TRAUMA AND ATTEMPTS BY THE VAD TEAM TO REPRODUCE THE EVENT WERE UNSUCCESSFUL. THE PATIENT WAS ASYMPTOMATIC. THE PATIENT WAS CONVERTED TO THE POCKET CONTROLLER. THE PATIENT WAS DISCHARGED AND WILL CONTINUE TO BE MONITORED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354121 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR