BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 2790154 · Received October 15, 2012

    Report

    Report Number
    6000030-2012-00176
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Report Date
    September 21, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE PUMP REPLACEMENT FOR END OF BATTERY LIFE ON (B)(6) 2012, THE CATHETER WAS ALSO REPLACED AS IT WAS "NOT FUNCTIONING." THE CATHETER WAS CHECKED DURING THE REPLACEMENT AND IT WAS NOTED THAT THE CATHETER WAS NOT FLOWING CEREBROSPINAL FLUID (CSF). THE EXACT ISSUE WITH THE CATHETER WAS UNKNOWN. THE REPORTER WAS UNSURE IF THE PATIENT EXPERIENCED ANY SYMPTOMS FROM THE EVENT; HOWEVER, THE PATIENT DID REQUIRE A VERY HIGH DOSE. THE DEVICE WAS USED TO DELIVER COMPOUNDED BACLOFEN AND BUPIVACAINE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627-18

    Patients

    Seq Age Sex Outcome Treatment
    1