BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1812477 · Received August 16, 2010

    Report

    Report Number
    3007566237-2010-06161
    Event Type
    Injury
    Date Received
    August 16, 2010
    Report Date
    July 19, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THE REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    ON (B)(6)2008, IT WAS REPORTED THAT PATIENT EXPERIENCED "UNDERDOSE" SYMPTOMS. NO ADDITIONAL INFORMATION WAS REPORTED. IN (B)(6) 2009, THE PATIENT COMPLAINED THAT WHEN THE PUMP WAS REFILLED, HE EXPERIENCED WITHDRAWAL SYMPTOMS. THE PATIENT EXPERIENCED THESE SYMPTOMS FOLLOWING 2 OF 3 REFILLS. ON (B)(6)2010, DURING REVISION SURGERY, IT WAS DISCOVERED THE CATHETER WAS OVER THE PUMP REFILL PORT. THE PROXIMAL CATHETER WAS REPLACED AS WELL AS THE PUMP. THE PUMP DELIVERED COMPOUNDED BACLOFEN 0.1 MG/ML AND MORPHINE 2.5 MG/ML. PATIENT'S OUTCOME POST REPLACEMENT WAS NOT REPORTED. 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
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8840, LOT # UNK| EXPLANTED:| CATHETER: MODEL 8731, LOT # N004041006| CATHETER: MODEL 8598A, LOT # N108958008| EXPLANTED: