BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3060385 · Received April 11, 2013

    Report

    Report Number
    2916596-2013-00432
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 15, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORT THAT THE PT PRESENTED TO THE EMERGENCY ROOM WITH SHORTNESS OF BREATH. A REVIEW OF THE SYSTEM CONTROLLER HISTORY LOG SHOWED LOW SPEED AS WELL AS PUMP STOP EVENTS THAT ACCORDING TO THE LOG HAD OCCURRED THE PREVIOUS DAY. THE PT WAS ADMITTED AND HIS PERCUTANEOUS LEAD WAS EVALUATED. A SMALL AREA OF RESCUE TAPE NEAR THE DISTAL END WAS REMOVED. THE OUTER SILICONE WAS PARTIALLY REMOVED TO CHECK FOR DAMAGED AND OR BROKEN WIRES. THE BIONATE WAS A DARK GREEN COLOR AND OPAQUE. A PHASE INTERRUPTER WAS USED AND A FRACTURED RED WIRE WAS CONFIRMED. THE PERCUTANEOUS LEAD WAS ALSO AGGRESSIVELY MANIPULATED WHILE CONNECTED TO A 14V PT CABLE AND THE LOW SPEED AND PUMP STOP EVENTS COULD NOT BE REPRODUCED. IT WAS SUSPECTED THAT THE FRACTURED WIRE IS INTERNAL. A DECISION WAS MADE TO EXCHANGE THE DEVICE. THE PUMP EXCHANGE WAS COMPLETED AND THE PT REMAINS ONGOING ON THE NEW LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156571 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1355 68822

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention