BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3030707 · Received March 22, 2013

    Report

    Report Number
    2916596-2013-00321
    Event Type
    Malfunction
    Date Received
    March 22, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 23, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO THE MFR FOR EVAL AS IT REMAINS IN USE. (B)(4). NO ADDITIONAL 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). APPROXIMATELY 17 MONTHS POST IMPLANT THE VAD COORDINATOR REPORTED THAT THE PT EXPERIENCED A RED HEART ALARM WHILE CONNECTED TO HIS 14V PT CABLE. THE PT EXCHANGED THE SYSTEM CONTROLLER AND THE ISSUE APPEARED TO BE RESOLVED. THE PT ONCE AGAIN BEGAN EXPERIENCING RED HEART ALARMS A FEW WEEKS LATER. HE WAS ADVISED TO COME TO THE HOSP AND HE PRESENTED TO THE VAD CLINIC THE FOLLOWING DAY. WHILE CONNECTING THE 14V PT CABLE TO VIEW THE PT'S EVENT HISTORY, THERE WAS A RED HEART ALARM AND THE SPEED DROPPED TO APPROXIMATELY 2300 RPM'S. HE WAS IMMEDIATELY RECONNECTED TO BATTERY POWER. THE VAD COORDINATOR SUSPECTED A POTENTIAL SHORT TO GROUND ISSUE OF THE PERCUTANEOUS LEAD. THE VAD COORDINATOR REQUESTED AN ON-SITE EVAL BY THORATEC TECHNICAL SERVICES AND THE PT WAS ADMITTED. THE PERCUTANEOUS LEAD WAS EVALUATED AND AN ISSUE WAS CONFIRMED, HOWEVER, A SPECIFIC EXTERNAL AREA COULD NOT BE IDENTIFIED. A THORATEC TECHNICAL SERVICE REP COMPLETED AN EXTERNAL PERCUTANEOUS LEAD REPLACEMENT. FOLLOWING THE REPLACEMENT, THE PT HAD ANOTHER RED HEART ALARM. A CUSTOM 14V PT CABLE WITH THE GROUND REMOVED WAS PROVIDED TO THE PT. HE WAS DISCHARGED HOME AND HAS HAD NO FURTHER ALARMS. THE MFR ALSO RECEIVED THE USER FACILITY REPORT ((B)(4)) FROM THE (B)(4) REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119566 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 106449

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other