BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1040503 · Received May 9, 2008

    Report

    Report Number
    2182207-2008-02514
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 10, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS HAVING A CHANGE IN THERAPY EFFECT AND WAS FLACCID. THE PT WAS IMPLANTED WITH A NEW PUMP AND CATHETER ABOUT 2 DAYS PRIOR TO THE CALL AND THE SYMPTOM BEGAN SOMETIME FOLLOWING IMPLANT BUT TIMING WAS NOT SPECIFIED. THE PT WAS GETTING 25 MCG/ML WITH 500 MCG/ML LIORESAL DRUG CONCENTRATION. ADD'L INFO HAS BEEN REQUESTED.

    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 UNK Required Intervention PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED| CATHETER MODEL CATHETER LOT# UNK| EXPLANTED| IMPLANTED| IMPLANTED