BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3940971 · Received June 25, 2014

    Report

    Report Number
    2916596-2014-01062
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS ADMITTED (B)(6) 2014 WITH LDH >50000, DARK URINE, AND POTENTIAL THROMBUS. THE VAD COORDINATOR ALSO REPORTED SPEED FLUCTUATIONS 60-100 RPM. SILICONE PULLED APART ON DRIVELINE AT INSERTION AREA OF CONTROLLER X-RAY OF DRIVELINE AND LOG FILES SENT (B)(6) 2014 TO RULE OUT INTERNAL LEAD FRACTURE: THE LOG FILE HAS BEEN REVIEWED; THE LOG CAPTURED A FEW SPEED DROPS WITH THE LOWEST BEING 9280 AND NEVER BELOW THE LOW SPEED LIMIT. THERE WAS ALSO ONE EVENT OF A POWER ELEVATION OF 10.1 ASSOCIATED WITH A PI EVENT. NO OTHER ADVERSE ALARMS OR EVENTS CAPTURED IN THE APPROX 6 DAY LOG. THERE WAS NO INDICATION OF A DRIVELINE ISSUE IN THE LOG FILE OR IN THE X-RAY SUBMITTED. THE PT WAS PLACED ON A HIGH DOSE OF HEPARIN AND BEING MONITORED CURRENTLY. IF PRESUMED THROMBUS DOES NOT RESOLVE, PUMP EXCHANGE PLANNED FOR (B)(6) 2014. IF THE LDH AND HEMATURIA RESOLVES WITH HEPARIN, PLAN FOR CLAMSHELL APPLICATION ON (B)(6) 2014. LDH INCREASING, CREATININE INCREASING TO 3.0 DESPITE HEPARIN THERAPY. DECISION MADE FOR PUMP EXCHANGE. PUMP EXCHANGED PERFORMED (B)(6) 2014, THE PT TOLERATED OPERATION WELL, CONTINUE TO MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369781 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 127755

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention