BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2843491 · Received November 19, 2012

    Report

    Report Number
    2916596-2012-01140
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 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 REMAINS IN USE SUPPORTING THE PT. NO FURTHER 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 PATIENT IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT CALLED THE HOSPITAL AND STATED THAT HE EXPERIENCED RED HEART ALARMS BUT WAS FEELING FINE. THE PT DID NOT HAVE ANY CHEST PAINS, SHORTNESS OF BREATH, ANXIETY, DIAPHORESIS OR NAUSEA. THE PT CALLED THE HOSPITAL BACK SHORTLY AFTER AND REPORTED THAT RED HEART AND LOW FLOW ALARMS OCCURRED. THE PT¿S SPOUSE STATED THAT THE PT¿S FLOW CONTINUED TO REGISTER AT 4.6 LPM. THE PT EXCHANGED THE SYSTEM CONTROLLER AND BATTERY CLIPS WITHOUT RESOLUTION OF THE ALARMS. A NO FLOW ALARM THEN OCCURRED AND THE PT WAS INSTRUCTED TO GO TO HIS LOCAL EMERGENCY DEPARTMENT. ECHO IMAGES WERE DIFFICULT TO READ, BUT THE AORTIC VALVE OPENED WITH EVERY BEAT AND THE LEFT VENTRICLE (LV) SIZE APPEARED TO BE UNLOADED BUT COULD NOT BE MEASURED. IT WAS REPORTED THAT THE PT¿S WIFE HAD TRIPPED OVER THE PT¿S POWER MODULE PT CABLE AND SHE WAS UNABLE TO CARE FOR THE PT AS A RESULT OF AN INJURY. THE PT WAS IN ATRIAL FLUTTER. THE RHYTHM WAS FIXED AND THE VAD FLOW WAS RESTORED TO NORMAL. IT WAS DETERMINED THAT THE PT¿S SPOUSE USUALLY MANAGED HIS MEDICATIONS. THE VAD COORDINATOR BELIEVES THAT WHEN THE PT¿S SPOUSE WAS IN THE HOSPITAL, THE PT MIXED UP HIS MEDICATIONS, AND DID NOT TAKE HIS COREG (50 MG BID) AND TOOK EXTRA COUMADIN, WHICH ACCOUNTED FOR THE ATRIAL FLUTTER WITH RVR AND ELEVATED INTERNATIONAL NORMALIZED RATIO (INR). 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. 104911 105180

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention