BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3181305 · Received June 12, 2013

    Report

    Report Number
    2916596-2013-00679
    Event Type
    Injury
    Date Received
    June 12, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 17, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ONGOING WITH THE IMPLANTED DEVICE. THE USER FACILITY REPORT #(B)(4) WAS RECEIVED FROM THE (B)(4) REGISTRY. 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PT WAS HAVING POWER ELEVATIONS. A (B)(4) STUDY WAS PERFORMED IN CLINIC AND AV WAS STILL OPENING AT 10,000 RPM AND PT HAS 3+AL. THE PT WAS ASYMPTOMATIC, BUT WAS HAVING WORSENING AORTIC VALVE INSUFFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266112 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 117494

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention