BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2840650 · Received November 20, 2012

    Report

    Report Number
    3007566237-2012-02789
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    October 24, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED INCREASED PAIN WITH NEUROPATHY IN THEIR BILATERAL LOWER EXTREMITIES. A CT SCAN WAS DONE PRIOR TO PUMP REPLACEMENT AND REVEALED A FRACTURE OF THE CATHETER. THERE WAS A FRACTURE OF THE CATHETER AT THE PARA SPINOUS. THEY WERE UNABLE TO REMOVE THE SPINAL SEGMENT FROM THE INTRATHECAL SPACE. SURGERY WAS PERFORMED AND A NEW CATHETER WAS PLACED. THE PUMP CHANGE OUT WAS DONE AT SAME TIME DUE TO END OF LIFE. PATIENT STATUS WAS ALIVE WITH NO INJURY AND NO ADVERSE EVENT. THE PUMP WAS DELIVERING MORPHINE BUPIVACAINE AND FENTANYL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention