BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2885066 · Received December 19, 2012

    Report

    Report Number
    2916596-2012-01230
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP IS STILL IN USE SUPPORTING THE PT; HOWEVER, THE REPLACED PORTION OF THE PERCUTANEOUS LEAD WAS RETURNED TO THE MANUFACTURER FOR EVAL. NO FURTHER INFO 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WENT TO THE PT CLINIC AND STATED THAT WHEN HE WAS CONNECTED TO THE POWER CABLE AT HOME, ONLY 2 OF THE 4 GREEN LEDS WOULD ILLUMINATE ON HIS SYSTEM CONTROLLER, BUT WHEN HE WAS ON BATTERY POWER, 4 GREEN LEDS ILLUMINATED. THE PT WAS CONNECTED TO THE POWER MODULE AT THE CLINIC AND A RED HEART ALARM OCCURRED WITH SPEED DROPS INTO THE 4,000 RPM RANGE. THERE WAS ALSO A COMMUNICATION ERROR ALARM. THE PT REPORTED FEELING "FUNNY" WITH THE SPEED DROPS. THE PT CABLE, SYSTEM CONTROLLER, POWER MODULE AND SYSTEM MONITORS WERE EXCHANGED WITHOUT RESOLUTION WHILE THE PT WAS ON THE POWER MODULE. WHEN THE PT WAS PLACED ON BATTERY POWER THE ALARMS WERE RESOLVED. IT WAS ALSO REPORTED THAT THE PT HAD SEVERAL AREAS OF CUTS IN THE SILICONE COVERING OF HIS DRIVELINE. THE PT WAS ADMITTED INTO THE HOSPITAL AND PLACED ON BATTERY POWER. A FEW ATTEMPTS WERE MADE TO CONNECT THE PT TO THE POWER MODULE AND SYSTEM MONITOR; HOWEVER, THE ISSUE CONTINUED. THE PERCUTANEOUS LEAD WAS EVALUATED AND A DECISION WAS MADE TO REPLACE THE DISTAL END OF THE PERCUTANEOUS LEAD. THE MANUFACTURER'S TECHNICAL SUPPORT REP REPLACED THE DISTAL END OF THE PERCUTANEOUS LEAD. THE PT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1355 77241

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention