BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1051093 · Received May 22, 2008

    Report

    Report Number
    2182207-2008-02748
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 22, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED INCREASED SPASTICITY THE EVENING FOLLOWING A REFILL SESSION. THE PUMP WAS ASPIRATED AND 0.5 CC WAS PULLED FROM THE RESERVOIR. THE HCP BELIEVED THERE WAS A POCKET FILL. THE PUMP WAS REFILLED AND THE HCP PLANNED TO DELIVER A SINGLE THERAPEUTIC BOLUS. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WAS NOT REPORTED; DEVICE REGISTRATION SYSTEM INDICATES BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8709 LOT# J0039990R| IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED: