BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2231102 · Received August 26, 2011

    Report

    Report Number
    3007566237-2011-06962
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    August 11, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT WAS SCHEDULED FOR A "NORMAL" DEVICE REPLACEMENT SURGERY. THE CATHETER WAS ASPIRATED THROUGH THE CATHETER ACCESS PORT (CAP) TO DETERMINE CATHETER PATENCY; AND WHETHER THE CATHETER NEEDED TO BE REPLACED AS WELL. AFTER THE CAP ASPIRATION, THE CATHETER WAS PRIMED. LATER, THE PT EXPERIENCED UNDERDOSE/WITHDRAWAL SYMPTOMS AND INCREASED TONE. IT WAS NOTED THE PUMP WAS IN SAFE STATE. THE HCP ATTEMPTED TO PROGRAM THE PUMP OUT OF THE SAFE STATE, IN AN ATTEMPT TO CONTINUE THERAPY FOR AS LONG AS POSSIBLE. A PUMP REPLACEMENT SURGERY WAS RE-SCHEDULED TO OCCUR AS SOON AS POSSIBLE. IT WAS LATER REPORTED THE PUMP DELIVERED LIORESAL (200 MCG/ML 890 MCG/DAY). THE SPECIFIC SYMPTOMS OF WITHDRAWAL THE PT EXPERIENCED WERE: HYPERTONIA, SEIZURES, AND FEVER. WHEN THE HCP TRIED TO RESTART THE PUMP BACK INTO SIMPLE CONTINUOUS MODE, THE PUMP WOULD NOT STAY IN THIS MODE AND WOULD FALL BACK INTO SAFE MODE. THE PUMP WAS REPLACED. THE PT'S OUTCOME WAS NOTED AS BEING "GOOD".

    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 24 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J12368R22