BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHER PULMONARY

    MDR report key: 3071061 · Received April 22, 2013

    Report

    Report Number
    2025587-2013-00060
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    November 12, 2012
    Report Date
    March 28, 2013
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    NPV
    PMA / PMN Number
    H080002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED AND THEREFORE WAS NOT RETURNED FOR ANALYSIS. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. PER THE MELODY INSTRUCTIONS FOR USE (IFU), ARRHYTHMIAS ARE A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING IMPLANTATION OF THE DEVICE. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIRTEEN MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT UNDERWENT AN ABLATION FOR TREATMENT OF AN ARRHYTHMIA. FOLLOWING THE ABLATION, THE PATIENT WAS ADMITTED OVERNIGHT FOR PAROXYSMAL VENTRICULAR TACHYCARDIA AND WAS NOTED TO HAVE INCREASED FREQUENCY OF THE ARRHYTHMIA. THE PATIENT TOLERATED THE ABLATION WELL AND WAS DISCHARGED HOME THE FOLLOWING DAY. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. THE VALVE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172492 MELODY TRANSCATHER PULMONARY PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV HEART VALVES SANTA ANA PB1018

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention