BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 1811088 · Received August 10, 2010

    Report

    Report Number
    2025587-2010-00088
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    January 12, 2009
    Report Date
    July 28, 2010
    Manufacturer
    MEDTRONIC HEART VALVE INC.
    Product Code
    NPV
    PMA / PMN Number
    H080002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION = CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MFG SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED AND WOULD HAVE IMPACTED THIS EVENT. WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS TRANSCATHETER PULMONARY VALVED CONDUIT, IMPLANTED 2 YEARS, HAS THREE STENT FRACTURES WITH NO LOSS OF STENT INTEGRITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MELODY TRANSCATHETER PULMONARY VALVE NPV MEDTRONIC HEART VALVE INC. PB 10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other