BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2894219 · Received December 27, 2012

    Report

    Report Number
    2916596-2012-01266
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    November 2, 2012
    Report Date
    December 8, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LVAD REMAINS IMPLANTED WITH THE PT. A SYSTEM CONTROLLER, SERIAL NUMBER (B)(4) AND A 14V POWER MODULE PT CABLE, LOT NUMBER 34990390611 WERE RETURNED FOR INVESTIGATION. THE USER FACILITY REPORT WAS REC'D FROM THE (B)(6) 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 PERFUSIONIST REPORTED THAT THE PT REC'D A STEADY TONE ALARM WITH NO LIGHTS ON THE SYSTEM CONTROLLER. ALL CONNECTIONS WERE CHECKED BY THE PT AND WERE ALL CONNECTED. WHEN THE SYSTEM CONTROLLER WAS CONNECTED TO THE POWER MODULE PT CABLE BY THE WHITE LEAD, THE CONNECTION SEEMED INTERMITTENT FOR A FEW SECONDS. AN (B)(6) REPORT WAS ALSO REC'D, WHICH INDICATED THAT THE PT EXPERIENCED PUMP STOPPAGES FOR ABOUT 10 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 114397

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention