BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1252021 · Received December 4, 2008

    Report

    Report Number
    2182207-2008-08023
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 5, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR THE PAST SIX MONTHS THE PATIENT HAS EXPERIENCED A LOSS OF THERAPEUTIC EFFECT DESPITE INCREASES IN MEDICATION DOSAGES. THE PATIENT DID NOT EXPERIENCE ANY WITHDRAWAL SYMPTOMS. AN EXPLORATORY CATHETER SURGERY WAS DONE. WHEN THE CATHETER WAS DISCONNECTED, THE RETROGRADE FLOW OF FLUID FROM THE CATHETER WAS SLOW. THE NEUROSURGEON DECIDED TO REPLACE THE CATHETER. THE PUMP WAS USED TO DELIVERY LIORESAL 2000MCG/ML. PRIOR TO THE CATHETER REPLACEMENT, THE PATIENT WAS RECEIVING 790.7MCG/DAY. FOLLOWING THE CATHETER REPLACEMENT, THE DOSAGE WAS REPROGRAMMED TO 96MCG/DAY. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention EXPLANTED| PROGRAMMER: MODEL 8840| CATHETER: MODEL 8709