BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202137 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00258
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    April 13, 2012
    Report Date
    April 14, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS ON (B)(6) 2012. THE PATIENT WAS UNABLE TO SEE THEIR PHYSICIAN DUE TO AVAILABILITY SO THE PATIENT WENT TO THE EMERGENCY ROOM ON (B)(6) 2012. THE PUMP WAS CHECK AND AN X-RAY WAS DONE OF THE CATHETER. IT WAS DETERMINED THAT THE PATIENT HAD A URINARY TRACT INFECTION (UTI) WHICH WAS AFFECTING THE WAY THE PUMP WAS WORKING. THE PATIENT WAS EXPERIENCING ¿SEVERE¿ SPASTICITY. THE PATIENT WAS USING ORAL BACLOFEN TO REDUCE THEIR SYMPTOMS. IT WAS DESCRIBED THAT IT WAS IF THE PATIENT DID NOT EVEN HAVE THE PUMP. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301876 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00020 YR