BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 2243792 · Received July 29, 2011

    Report

    Report Number
    2025587-2011-00099
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    December 28, 2010
    Report Date
    July 25, 2011
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    NPV
    PMA / PMN Number
    H080002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION METHOD: DEVICE HISTORY COULD NOT BE REVIEWED AS THE SERIAL NUMBER WAS NOT PROVIDED. RESULTS: NO PRODUCT WAS RETURNED. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A CLINICAL STUDY REPORT, THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE THE STENT FRACTURED (TYPE 1), WITHOUT THE LOSS OF STENT INTEGRITY. NO TREATMENT WAS GIVEN AND THERE WERE NO ADVERSE PATIENT EFFECTS.

    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