BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2894201 · Received December 27, 2012

    Report

    Report Number
    2916596-2012-01250
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 4, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. THE ATTACHED USER FACILITY REPORT WAS REC'D FROM THE (B)(4). 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 FELT THAT THE PUMP HAD STOPPED AND EXPERIENCED RANDOM ALARMS ON THE POWER MODULE ONLY WITH CHANGES IN POSTURE/POSITIONING. THE PT REC'D A PUMP EXCHANGE ON (B)(6) 2012.

    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 103695 98106

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention