BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HM II LVAS EUROPE

    MDR report key: 2191576 · Received July 20, 2011

    Report

    Report Number
    2916596-2011-00302
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. APPROX 2 YEARS POST-IMPLANT, THE PT REPORTED SPONTANEOUS RED HEART ALARMS FOR THE LAST FEW DAYS. THE VAD COORDINATOR CHECKED THE HISTORY AND VERIFIED THE ALARMS. THE SYSTEM CONTROLLER HISTORY ALSO SHOWED DECREASES IN SPEED AND LOW FLOW HAZARD ALARMS. THE PT WAS ABLE TO REPRODUCE THE ALARMS WITH CERTAIN MOVEMENTS AND ADMITTED THAT HE DROPPED THE BAG THAT CONTAINED THE SYSTEM CONTROLLER AND BATTERIES ON (B)(6) 2011 AND THAT THE ALARMS BECAME MORE FREQUENT SINCE THIS OCCURRED. ALTHOUGH, AN X-RAY TAKEN OF THE INTERNAL PORTION OF THE PERCUTANEOUS LEAD WAS UNREMARKABLE, THE CLINIC SUSPECTED DAMAGE TO THE INTERNAL PORTION OF THE PERCUTANEOUS LEAD AND A DECISION WAS MADE TO EXCHANGE THE PUMP TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HM II LVAS EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 102139 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention