BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2720266 · Received August 30, 2012

    Report

    Report Number
    3004209178-2012-07522
    Event Type
    Injury
    Date Received
    August 30, 2012
    Report Date
    August 8, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8598A, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER PRODUCT ID 8590-1, LOT# N080146, SERIAL# IMPLANTED: (B)(6) 2007, EXPLANTED: PRODUCT TYPE ACCESSORY PRODUCT ID 8575, LOT# N092195, SERIAL# IMPLANTED: (B)(6) 2007, EXPLANTED: PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DID NOT SEEM TO BE RECEIVING BENEFITS OF THE THERAPY. THE PATIENT EXPERIENCED INCREASED SPASTICITY. WHEN A NURSE TRIED TO ASPIRATE CEREBROSPINAL FLUID (CSF) THROUGH THE CATHETER ACCESS PORT (CAP) SHE WAS UNABLE TO DO SO. WHEN THE SURGEON OPENED UP THE SPINE AND DISCONNECTED THE SPINAL SEGMENT THERE WAS NO CSF FLOW AND HE WAS UNABLE TO ASPIRATE THROUGH THE CATHETER SO HE REPLACED THE SPINAL SEGMENT. ONCE THE NEW SPINAL SEGMENT WAS ATTACHED THERE WAS GOOD CSF FLOW AND THE SURGEON CONNECTED THE CATHETER. NO PATIENT INJURY WAS REPORTED. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention