BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3022532 · Received March 21, 2013

    Report

    Report Number
    2916596-2013-00293
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    December 6, 2011
    Report Date
    February 22, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR WAS ADVISED THAT THE EXPLANTED LVAD PUMP WILL NOT BE RETURNING FOR EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED. THE USER FACILITY REPORT (B)(4) WAS RECEIVED FROM THE (B)(4) REGISTRY

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MFR RECEIVED USER FACILITY REPORT (B)(4) FROM THE (B)(4) REGISTRY INDICATING THAT "SEPTIC THROMBUS IN LVAD, PTS LVAD WAS INTERROGATED AND FOUND TO BE DYSFUNCTIONING WITH LOW FLOWS." ADDITIONAL INFO WAS RECEIVED BY THE MFR FROM THE HOSP CSS COORDINATOR ADVISING THAT THE PT WAS TRANSPLANTED ON (B)(6) 2012 AND THE HOSP DOES NOT HAVE THE PUMP TO RETURN FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117389 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 108207

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention