BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3072556 · Received April 23, 2013

    Report

    Report Number
    3007566237-2013-01394
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    March 26, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT EXPERIENCED WEAKNESS OVER THE SPAN OF EIGHT MONTHS. THE PATIENT WAS AMBULATORY SIX MONTHS AGO, HAD PROGRESSIVE LEG WEAKNESS AND NOW UTILIZED A WHEELCHAIR. A MAGNETIC RESONANCE IMAGING (MRI) SCAN WAS PERFORMED. THE NEUROSURGEON REVIEWED THE FILMS AND STATED A MASS WAS PRESENT AT THE TIP OF THE CATHETER AND NEEDED TO BE REMOVED. THE PHYSICIAN PLANNED TO MOVE THE CATHETER TIP TO A LOWER LEVEL AND SEND THE PATIENT FOR FREQUENT MRI'S TO MONITOR FOR THE DEVELOPMENT OF ANOTHER MASS. THE SURGERY WAS SCHEDULED; THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS REPORTED AS ALIVE WITH INJURY. THIS DEVICE SYSTEM DELIVERED LIORESAL. IT WAS LATER REPORTED THAT THERAPY WAS RESUMED. THE NEUROSURGEON SUCCESSFULLY REMOVED THE MASS AND THE CATHETER TIP WHICH WAS SENT FOR CULTURE. THE CATHETER WAS MOVED DOWN THREE VERTEBRAL BODIES. THE PATIENT DID HAVE LACK OF MOTOR POST-SURGERY. HOWEVER, THE PUMP SYSTEM SEEMED TO BE WORKING. FURTHER REPORTED, THE PATIENT STILL HAD NO MOTOR RETURN IN THE LOWER EXTREMITIES AND WAS IN REHABILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174773 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R