BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3780745 · Received April 22, 2014

    Report

    Report Number
    2916596-2014-00636
    Event Type
    Injury
    Date Received
    April 22, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE DEVICE NOT BEING AVAILABLE FOR EVALUATION, A SPECIFIC CAUSE FOR THE REPORTED PUMP POCKET INFECTION AND A CORRELATION TO THE DEVICE COULD NOT CONCLUSIVELY BE DETERMINED. THE PATIENT REMAINED ONGOING ON LVAD SUPPORT UNTIL THEY UNDERWENT A PUMP EXCHANGE ON (B)(6) 2014 DUE TO AN UNRELATED ISSUE. THE HOSPITAL DID NOT RETURN THE PUMP. NO PRODUCT IS AVAILABLE FOR INVESTIGATION. PUMP POCKET INFECTIONS ARE LISTED IN THE DEVICE¿S INSTRUCTIONS FOR USE (IFU) AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    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 (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT DEVELOPED A PUMP POCKET INFECTION. THE PT WAS READMITTED AND TREATED FOR INFECTION. THERE ARE NO CURRENT PLANS FOR EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243817 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP 104911 123080

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention