BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1884834 · Received October 15, 2010

    Report

    Report Number
    3004209178-2010-08008
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 20, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PATIENT'S INTRATHECAL CATHETER HAD FRACTURED. THE PATIENT EXPERIENCED AN UNDERDOSE WITH INCREASED STIFFNESS. THE PATIENT WAS SEEN IN THE ER OVER THE WEEKEND WITH THE SYMPTOMS AND WAS TREATED WITH ORAL MEDICATIONS. THE DRUG USED IN THE PUMP WAS BACLOFEN; DOSE AND CONCENTRATION WERE UNKNOWN. THE PATIENT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N255304004