BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMMAYA RESERVOIR

    MDR report key: 202531 · Received December 18, 1998

    Report

    Report Number
    2132740-1998-00025
    Event Type
    Death
    Date Received
    December 18, 1998
    Date of Event
    August 22, 1998
    Report Date
    December 4, 1998
    Manufacturer
    UNK
    Product Code
    BTC
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED OF AN ALLEGED INCIDENT WITH A PT THAT HAD AN OMMAYA RESERVOIR IMPLANT. THE PT WAS INJECTED WITH INTRATHECAL METHOTREXATE BY A PHYSICIAN'S ASSISTANT ON 06/30/1998. THE PT EXPERIENCED HALLUCINATION. PT INFARCT ONE HALF OF THE BRAIN. THE PT EXPIRED ON 08/22/1998. THERE HAS BEEN NO ACKNOWLEDGMENT FROM THE HOSP OF AN INCIDENT WITH AN OMMAYA RESERVOIR. THERE HAS BEEN NO ACKNOWLEDGMENT OF A MALFUNCTION WITH AN OMMAYA RESERVOIR. CO CANNOT CONFIRM THAT THE OMMAYA RESERVOIR IS CO'S PRODUCT. ALL OF THE INFO WAS PROVIDED VIA PHONE CALL BY SALES REP AND HAS NOT BEEN CONFIRMED BY THE HOSP. CO CANNOT CONFIRM THE HOSP, THE PHYSICIAN, THE PRODUCT OR DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMMAYA RESERVOIR Implant * BTC UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death