BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPEN PIVOT MECHANICAL HEART VALVE

    MDR report key: 2042056 · Received March 28, 2011

    Report

    Report Number
    2134151-2011-00003
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    MEDTRONIC ATS, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), DEVICE HISTORY REVIEWED. RESULTS - DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSIONS - CAUSE OF EVENT CANNOT BE DETERMINED. NO PRODUCT HAS BEEN RETURNED. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEW AND SHOWED THAT THIS VALVE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS BIOPROSTHETIC VALVE, THE VALVE DID NOT APPEAR TO OPEN SMOOTHLY. THE VALVE WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS. IT WAS REPORTED THAT THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPEN PIVOT MECHANICAL HEART VALVE LWQ MEDTRONIC ATS, INC. 500DM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention