BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MELODY TRANSCATHER PULMONARY VALVE

    MDR report key: 2082615 · Received April 27, 2011

    Report

    Report Number
    2025587-2011-00057
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 17, 2010
    Report Date
    April 12, 2011
    Manufacturer
    THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG
    Product Code
    NPV
    PMA / PMN Number
    H080002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECS 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 SPEC FOR PRODUCTS 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 PULMONARY VALVE REPLACEMENT SYSTEM, IMPLANTED 4 YEARS, EXHIBITED A MINOR STENT FRACTURE WITHOUT LOSS OF INTEGRITY SEEN ON CHEST X-RAY. NO ADVERSE PT EFFECTS WERE REPORTED AND NO INTERVENTION IS PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MELODY TRANSCATHER PULMONARY VALVE NPV THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG PB 10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other