BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA

    MDR report key: 2946069 · Received February 6, 2013

    Report

    Report Number
    2025587-2013-00013
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    February 23, 2011
    Report Date
    September 16, 2011
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED ON (B)(4) 2013 BUT DUE TO A FDA OUTAGE, THE SUBMISSION WAS UNSUCCESSFUL. THUS, THE REPORT IS BEING RESUBMITTED ON (B)(4) 2013. PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED AND THEREFORE, HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. CONCLUSION: THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED AS THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. 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 AN UNKNOWN DURATION FOLLOWING THE IMPLANT OF THIS PULMONARY VALVED CONDUIT, STENOSIS AND REGURGITATION WERE NOTED. A BIOPROSTHETIC TRANSCATHETER VALVE WAS IMPLANTED WITHIN THE CONDUIT TO RESOLVE THE ISSUE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50111 CONTEGRA CONDUIT,VALVED,PULMONIC MWH HEART VALVES SANTA ANA 200S

    Patients

    Seq Age Sex Outcome Treatment
    1 00013 YR Required Intervention