BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2150987 · Received June 21, 2011

    Report

    Report Number
    3007566237-2011-04617
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A "NORMAL PUMP REPLACEMENT", THE HCP NOTICED THAT THE SUTURELESS CONNECTOR LEAKED WHEN RE-CONNECTED TO A NEW PUMP. THE HCP CONFIRMED THE LEAK BY RECONNECTING IT TWICE AND STATED THAT THE SUTURELESS CONNECTOR PORTION ONLY WAS REPLACED WITH NEW WHILE THE INTRATHECAL AND TUNNELLED PORTION REMAINED IN THE PATIENT. THE PUMP WAS BEING USED WITH LIORESAL IT AT A DAILY DOSE OF 199.9MCG AND A CONCENTRATION OF 2,000 MCG/ML. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE REPORTED IF IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J53381R05| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N138060030| EXPLANTED: