BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN PUDENZ VALVE

    MDR report key: 2111087 · Received May 24, 2011

    Report

    Report Number
    2648988-2011-00021
    Event Type
    Other
    Date Received
    May 24, 2011
    Date of Event
    March 15, 2011
    Report Date
    May 24, 2011
    Manufacturer
    INTEGRA, ANASCO
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A (B)(6) MALE PT WITH HYDROCEPHALUS AND A HISTORY OF A "SPOT ON HIS LEFT LUNG" REPORTED THAT HE HAD A PUDENZE VALVE IMPLANTED IN (B)(6) 2004 (PRODUCT ID AND LOT/SERIAL NUMBER UNK). THE VALVE HAS BEEN WORKING FINE. APPROX ONE MONTH AGO ((B)(6) 2011), HE FELL AND HEARD A POPPING SOUND IN THE CENTER OF HIS CHEST. HE FELT DIZZY AND HAD AN ARRYTHMIA WHICH HE DESCRIBED AS "A RAPID HEART RATE WHICH WENT UP TO 124 BEATS/MINUTE." THIS EVENT LASTED SEVERAL HOURS; HOWEVER, HE DID NOT SEEK MEDICAL ATTENTION. OVER A PERIOD OF SEVERAL WEEKS, HE DEVELOPED A PERSISTENT COUGH. HE WAS SEEN BY HIS PULMONOLOGIST AND A CT SCAN WAS DONE. THE CT SCAN SHOWED A DIFFERENCE FROM A PREVIOUS SCAN AND INDICATED THAT A PIECE OF THE VALVE WAS IN THE RIGHT ATRIUM OF HIS HEART. ON (B)(6) 2011, HE EXPERIENCED THE DIZZINESS AND THE ARRYTHMIA AGAIN. THIS EPISODE LASTED THREE HOURS. SURGERY WAS DONE ON (B)(6) 2011 AT (B)(6) TO REMOVE THE BROKEN VALVE. FOUR TO FIVE INCHES OF THE DISTAL END OF THE VALVE WAS REMOVED. THE PT RECOVERED, WAS DISCHARGED AND IS NOW HOME DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PUDENZ VALVE NA JXG INTEGRA, ANASCO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R