BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 2181282 · Received July 21, 2011

    Report

    Report Number
    3007566237-2011-05632
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P86004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AROUND (B)(6) 2011, THE PT EXPERIENCED AN INCREASE IN SYMPTOMS. THERE WAS NO REDUCTION IN SYMPTOMS DESPITE PUMP RATE INCREASES. CATHETER ACCESS PORT TESTING RESULTS INDICATED THERE WAS LEAKAGE AT THE PUMP CONNECTION; THERE WAS DYE POOLING IN THE POCKET. THE CATHETER WAS REPLACED (B)(6) 2011 DUE TO A SUSPECTED CATHETER OCCLUSION. THE PT STATUS AFTER THE DEVICE WAS REMOVED WAS REPORTED AS RECOVERED WITHOUT SEQUELAE. THE PUMP WAS USED TO DELIVER LIORESAL 1650 MCG/ML AT 410 MCG/DAY AND CLONIDINE. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER: MODEL 8709, LOT# N114686007| EXPLANTED:| IMPLANTED: