BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2894190 · Received December 27, 2012

    Report

    Report Number
    2916596-2012-01273
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    November 8, 2012
    Report Date
    December 4, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PT. 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 (LVAD). THE MFR REC'D THE ATTACHED USER FACILITY REPORT ((B)(4)) FROM THE (B)(6) REGISTRY. THE REPORTED STATED: "LEFT LOWER CHEST PRESSURE PROGRESSING ACROSS THE CHEST, ELEVATED MEAN ARTERIAL PRESSURE (MAP) WHICH CONTINUED AFTER TAKING BENZODIAZEPINE AND HYDRALAZINE. THE HOSPITAL ADMINISTERED NITROGLYCERIN AND MORPHINE. THE PT WAS FOUND TO HAVE ELEVATED TROPONIN I."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 107102

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention