BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1253168 · Received December 5, 2008

    Report

    Report Number
    6000030-2008-08042
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    July 30, 2007
    Report Date
    November 6, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER - CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SYSTEM WAS EXPLANTED. THE PUMP WAS EXPIRED. THE CATHETER WAS KINKED/OCCLUDED IN THE INTRATHECAL SECTION. NO PT SYMPTOMS WERE REPORTED. THE PT RECOVERED WITHOUT SEQUELA. THE PUMP WAS USED TO DELIVER BACLOFEN 25MCG/ML AT A DAILY RATE OF 5.246MCG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention PROGRAMMER MODEL PROGRAMMER| IMPLANTED:| CATHETER MODEL 8709| EXPLANTED: