BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3203526 · Received July 3, 2013

    Report

    Report Number
    3007566237-2013-00957
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Report Date
    July 25, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2005-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ONLY HAD RELIEF FOR THE FIRST YEAR SINCE IMPLANT WHEN MORPHINE WAS USED IN THE PUMP. THE PATIENT DID AN X-RAY THE WEEK PRIOR TO THE DATE OF THIS REPORT. THE X-RAY WAS INCONCLUSIVE SO THE DOCTOR DECIDED TO HAVE THE PATIENT DO A MAGNETIC RESONANCE IMAGING ON THE DATE OF THIS REPORT TO SEE IF THE PATIENT HAS A BULGING DISC OR NERVE PAIN. IT WAS NOTED THAT HE PUMP WAS ¿NOT WORKING.¿ THE PATIENT COULD HARDLY WALK SINCE (B)(6) 2012 AND SHE GOT ¿BURNING GOING DOWN BOTH SIDES OF HER LEGS.¿ THE PATIENT PLANNED TO SEE A DOCTOR THE WEEK AFTER THE DATE OF THIS REPORT FOR REFILL AND TO SEE IF SHE NEEDED ¿TO BURN SOME NERVE¿ OR HAVE A NERVE STIMULATOR IMPLANTED. THE PUMP WAS USED TO DELIVER DILAUDID AND AN UNKNOWN DRUG. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303942 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR