BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3190539 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10906
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8711 LOT# J10939R31, IMPLANTED: 2002 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿A COUPLE MONTHS AGO¿ THE PATIENT WENT TO THE HOSPITAL IN A (B)(6) BECAUSE HE HAD ¿SEVERE WITHDRAWALS,¿ THE PATIENT COULDN¿T REMEMBER WHEN THE EVENT OCCURRED, BECAUSE, HE WAS ¿OUT OF IT.¿ IT WAS NOTED THAT ¿THEY JUST DID A BUNCH OF TESTS¿ AND ¿THEY SENT [THE PATIENT] HOME.¿ ¿NOT MUCH¿ WAS DONE TO RESOLVE THE WITHDRAWAL. THE DEVICE SYSTEM WAS USED TO INFUSE BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290929 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Other