BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3162290 · Received May 22, 2013

    Report

    Report Number
    2916596-2013-00652
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PATIENT HAD A PUMP EXCHANGE DUE TO A PERCUTANEOUS LEAD FRACTURE IDENTIFIED NEAR THE PUMP, ON THE INTERNAL PORTION OF THE LEAD. THE FRACTURE WAS CAUSING A LOW SPEED HAZARD CONDITION WHERE THE SET SPEED WAS DROPPING BELOW THE AUTO LOW SETTING. THE LOG FILES CONFIRM THE LOW SPEED HAZARD. THE DECISION WAS MADE TO EXCHANGE THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226251 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 105148

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention