BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 2142553 · Received June 20, 2011

    Report

    Report Number
    2025587-2011-00072
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    October 4, 2010
    Report Date
    June 9, 2011
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    NPV
    PMA / PMN Number
    H080002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD: DEVICE HISTORY REVIEWED. 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 VALVE MET ALL MFG 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 F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS TRANSCATHETER BIOPROSTHETIC VALVE DEVELOPED A MINOR STENT FRACTURE. THE INTEGRITY OF THE STENT WAS PRESERVED. NO TREATMENT WAS NECESSARY AND THE VALVE REMAINS IMPLANTED. NO ADVERSE PT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other