BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3891226 · Received June 11, 2014

    Report

    Report Number
    2916596-2014-00946
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVALUATION. 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT WAS SEEN IN CLINIC WITH A HISTORY SCREEN THAT SHOWED LOW SPEED ALARMS. THE PATIENT STATED THAT THIS OCCURRED WHILE CONNECTED TO BATTERIES AND ON THE POWER MODULE WITH AN UNGROUNDED POWER MODULE PATIENT CABLE. THE ALARMS OCCURRED AGAIN IN CLINIC WHEN THE PATIENT MOVED INTO CERTAIN POSITIONS. THE VAD COORDINATOR CHANGED THE BATTERY CLIPS AND SYSTEM CONTROLLER WITHOUT ISSUE. THE PATIENT SUBSEQUENTLY WAS DISCHARGED HOME. WHEN HE ARRIVED HOME, THE PATIENT STATED THAT THE PUMP ALARMED AND STOPPED FUNCTIONING, AND THAT HE FELT A FLUTTER IN HIS CHEST. AS HE CHANGED POSITION, THE PUMP FUNCTION RETURNED. LOG FILES SUBMITTED TO THE MANUFACTURER FOR REVIEW DISPLAYED MULTIPLE RED HEART ALARMS, LOW SPEED AND LOW FLOW EVENTS, AS WELL AS INTERMITTENT PUMP STOPPAGES. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND AN EVALUATION OF THE PERCUTANEOUS LEAD WAS PERFORMED BY A MANUFACTURER'S TECHNICAL SERVICES TEAM MEMBER. NO BROKEN WIRES WERE FOUND. THE PATIENT EXPERIENCED INTERMITTENT PUMP STOPPAGES WHILE CONNECTED TO AN UNGROUNDED POWER MODULE PATIENT CABLE. THEY WERE UNABLE TO DETERMINE IF THE SUSPECT PERCUTANEOUS LEAD DAMAGE WAS INTERNAL AND/OR EXTERNAL. THE VAD COORDINATOR OPTED NOT TO PERFORM AN EXTERNAL PERCUTANEOUS LEAD REPAIR. ADD'L INF PROVIDED TO THE MANUFACTURER INDICATED THAT THE PATIENT'S LVAD WAS SUBSEQUENTLY EXCHANGED WITHOUT COMPLICATION DUE TO INTERNAL PERCUTANEOUS LEAD DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345632 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 122476

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention