BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3760801 · Received April 8, 2014

    Report

    Report Number
    2916596-2014-00544
    Event Type
    Injury
    Date Received
    April 8, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 14, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. 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 HAD HEMOLYSIS (ELEVATED LACTATE DEHYDROGENASE AND FREE HGB), HIGH POWER, AND WAS ADMITTED WITH CHEST PRESSURE. THE PT RECEIVED A PUMP EXCHANGE ON (B)(6) 2014. THE LOG FILE SHOWED THERE WAS ONE TRANSIENT POWER ELEVATION IN THE APPROX 10 DAY LOG FILE. THE REST OF THE LOG WAS UNREMARKABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210358 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 125084

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention