BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3073303 · Received April 23, 2013

    Report

    Report Number
    3007566237-2013-01407
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: CATHETER: PRODUCT ID 8578. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON CLIPPED THE CATHETER DURING A PUMP REPLACEMENT FOR NORMAL BATTERY DEPLETION. THE REPORTER WAS INQUIRING IF THE SURGEON COULD CLIP A CLEAN EDGE ON THE CATHETER AND PLUG IT INTO THE OLD CATHETER CONNECTOR. THE DEVICE SYSTEM WAS INFUSING CLONIDINE AND MORPHINE. FOUR DAYS LATER, IT WAS REPORTED THAT THE CATHETER WAS CLIPPED, APPROXIMATELY 6CM FROM THE PUMP CONNECTOR, WHEN THE SURGEON WAS DISSECTING THE POCKET. THE SURGEON WENT ON TO DISCARD THE CLIPPED SEGMENT AND WAS ABLE TO RECONNECT THE CATHETER BACK TO THE PUMP CONNECTOR. THE PUMP CONNECTOR WAS THEN ATTACHED TO THE PUMP AND TIED WITH SUTURES. AT THAT TIME, THE CATHETER AND PUMP CONNECTOR PATENCY WAS CHECKED VIA THE CATHETER ACCESS PORT AND CEREBROSPINAL FLUID WAS EASILY WITHDRAWN. IT WAS REPORTED THAT THE PATIENT HAD NOT EXPERIENCED ANY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175267 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention