BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1840024 · Received September 9, 2010

    Report

    Report Number
    3007566237-2010-06902
    Event Type
    Injury
    Date Received
    September 9, 2010
    Report Date
    August 18, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A FACILITY MEDWATCH MANUFACTURER'S REPORT # 0300240000-2010-8007 THAT A PATIENT WHO HAD BEEN IMPLANTED WITH A DEVICE FOR INTRATHECAL DELIVERY OF BACLOFEN, EXPERIENCED INCREASED SPASTICITY IN LEGS AND PAIN DOWN BILATERAL LEGS. THERE WAS A PUMP MOTOR STALL. THE DEVICE WAS EXPLANTED IN (B)(6) 2010. THE DOSAGE AND CONCENTRATION WERE UNKNOWN. 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 LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR