BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3001156 · Received March 8, 2013

    Report

    Report Number
    2916596-2013-00253
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 7, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO REPLACE DUPLICATE MDR NUMBER 0002916596-2013-00001. THE USER FACILITY REPORT# (B)(4) WAS RECEIVED FROM THE (B)(6) REGISTRY. THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVALUATION. 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). IT WAS REPORTED TO THE MANUFACTURER THAT THE PATIENT HAD BEEN COMPLAINING OF SEVERE CHEST PAIN DUE TO DEVICE PLACEMENT. THE PATIENT WAS ADMITTED AND THE PUMP WAS EXPLANTED. THE PATIENT WAS IMPLANTED WITH ANOTHER MANUFACTURER'S LVAD DEVICE. A DEVICE TRACKING FORM INDICATED THAT THE PATIENT WAS ISCHEMIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100356 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1355 71766

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention