BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2251390 · Received September 13, 2011

    Report

    Report Number
    2916596-2011-00394
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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 PERFUSIONIST REPORTED THAT THE HOSP MADE A DECISION TO EXCHANGE THE LVAD DUE TO ISSUES WITH THE INTERNAL PORTION OF THE PERCUTANEOUS LEAD. THE MFR HAD PROVIDED THE HOSP WITH A NON-GROUNDED PT CABLE FOR THE PT'S USE TO PREVENT SHORTING THAT WOULD LIKELY HAVE AFFECTED PUMP FUNCTION (REFERENCE MEDWATCH # 2916596-2011-00254). THE DEVICE WAS SUCCESSFULLY EXCHANGED WITH ANOTHER LVAD AND THE PT REMAINS ONGOING ON LVAD SUPPORT WITHOUT ANY FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 90057

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention