BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2950287 · Received February 6, 2013

    Report

    Report Number
    2916596-2013-00157
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORT# (B)(4) WAS RECEIVED FROM THE (B)(4) REGISTRY WHICH STATED THAT THE PATIENT EXPERIENCING A "POWER SURGE ASSOCIATED WITH RPM OF <8000." NO FURTHER INFORMATION 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). THE CARDIOLOGIST REPORTED THAT THE PATIENT HAD AN ALTERED LEVEL OF CONSCIOUSNESS BECAUSE OF HIS SEDATIVE MEDICATION (AMBIEN) AND DISCONNECTED THE SYSTEM CONTROLLER COMPLETELY FROM POWER FOR ABOUT 10 MINUTES. THE PATIENT'S SON HEARD THE ALARMS AND RECONNECTED THE SYSTEM CONTROLLER WHICH RESTARTED THE PUMP. THE PATIENT REPORTEDLY DID NOT EXPERIENCE ANY LOS, NEURO EVENT AND THE PUMP PARAMETERS REMAINED STABLE. THE PATIENT WAS TAKEN TO THE HOSPITAL BY FAMILY AND THE INTERNATIONAL NORMALIZED RATIO (INR) AND PUMP PARAMETERS WERE FOUND TO BE WITHIN NORMAL LIMITS (WNL). THE PATIENT WAS HOWEVER ADMITTED FOR FURTHER OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49750 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 116102

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention