BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1885179 · Received October 25, 2010

    Report

    Report Number
    3004209178-2010-08409
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    February 1, 2010
    Report Date
    September 28, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PT EXPERIENCED WITHDRAWAL FOLLOWING AN INCIDENT IN WHICH THE PT WAS TURNED AWAY FOR A REFILL IN (B)(6). IT WAS NOTED THAT THE PT WAS TURNED AWAY BY THE FACILITY, DUE TO NOT HAVING AN APPOINTMENT. THE PT WENT INTO A COMA IN (B)(6) FOR 13 DAYS AS A RESULT OF THE WITHDRAWAL, AND HAD SUFFERED SEIZURES. THE PT STATED THEIR NEXT REFILL HAD BEEN SCHEDULED FOR (B)(6). THE MOST RECENT REFILL HAD OCCURRED IN (B)(6). THE PT'S OUTCOME, IN ADDITION TO THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFO IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other CATHETER: MODEL 8731SC, LOT # N108359022| IMPLANTED:| EXPLANTED: