BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2890976 · Received December 31, 2012

    Report

    Report Number
    3007566237-2012-03157
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICE: PRODUCT ID: 8709, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS DUE FOR A PUMP REFILL ABOUT A MONTH AGO. THE PUMP WAS ALARMING AND HAD BEEN FOR ALMOST 3 WEEKS; TELEMETRY HAD NOT BEEN PERFORMED. THE PATIENT'S BACK PAIN WAS "GETTING WORSE BY THE DAY". THE PATIENT HAD CHANGED INSURANCES AND WAS THEN DISMISSED BY HER HEALTHCARE PROVIDER (HCP) APPROXIMATELY ONE AND A HALF MONTHS AGO. THE PATIENT WAS LOOKING FOR A NEW PHYSICIAN. THE PUMP WAS DELIVERING PRIALT, BACLOFEN, AND MORPHINE. IT WAS NOTED THAT THE PUMP HAD HELPED THE PATIENT A GREAT DEAL SINCE IMPLANT IN 2006. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1