BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2844155 · Received November 25, 2012

    Report

    Report Number
    3007566237-2012-02824
    Event Type
    Malfunction
    Date Received
    November 25, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INCREASED SPASTICITY. THE PATIENT MISSED A REFILL, AND THE PUMP WAS LEFT TO RUN EMPTY FOR 6 WEEKS. THE PATIENT WAS TO BE SEEN THE NEXT WEEK. IT WAS LATER REPORTED THAT THE PATIENT WAS ABLE TO BE REFILLED WITHOUT ANY DIFFICULTY. THE CATHETER WAS STILL FULL OF DRUG, SO THE PATIENT RECEIVED THERAPY ALMOST STRAIGHT AWAY AFTER REFILL. THE PATIENT WAS NOW DOING WELL, AND THE SPASTICITY WAS RESOLVED. THE DRUG IN THE PUMP WAS BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1