BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3021321 · Received March 26, 2013

    Report

    Report Number
    3007566237-2013-00891
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# J10956R29, IMPLANTED: (B)(6) 2001. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS ALARMING AS THE PATIENT WAS TWO WEEKS PAST HIS SCHEDULED REFILL. AT THE TIME OF REPORT, THE PHYSICIAN WAS ATTEMPTING TO REFILL THE RESERVOIR. THE PATIENT WAS SCREAMING FROM BEING IN "SO MUCH PAIN' FROM HIS SPASMS. IT WAS NOTED THAT THE PATIENT WAS ALWAYS "CONTRACTED", BUT THIS WASN'T HIS NORMAL BEHAVIOR. THE DRUG USED IN THIS SYSTEM WAS BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123269 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1