BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 4852329 · Received June 18, 2015

    Report

    Report Number
    2916596-2015-01120
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 21, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 64 DAYS. A SPECIFIC CAUSE FOR THE CHANGE IN THE PATIENT'S LACTATE DEHYDROGENASE LEVEL COULD NOT BE CONCLUSIVELY DETERMINED. THE PATIENT REMAINS ONGOING ON VAD SUPPORT. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. THE INSTRUCTIONS FOR USE LISTS HEMOLYSIS AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LVAS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT. PLACEHOLDER.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC FOR A ROUTINE FOLLOW UP, AND HIS LACTATE DEHYDROGENASE LEVEL WAS ELEVATED TO 604 U/L. THE PATIENT WAS TREATED WITH AN IV HEPARIN INFUSION ON (B)(6) 2015 AND PERSANTINE ON (B)(6) 2015. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398362 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention