BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2061725 · Received March 30, 2011

    Report

    Report Number
    3007566237-2011-02403
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    December 1, 2010
    Report Date
    March 21, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A CHANGE IN THERAPY EFFECT; THE PATIENT HAD INCREASED PAIN WHICH WAS NOTED TO BE SOMEWHAT NORMAL FOR THE PATIENT. A CATHETER DYE STUDY WAS ATTEMPTED IN DECEMBER, BUT THEY WERE NOT ABLE TO ASPIRATE. IT WAS NOTED THAT THE ACTUAL RESIDUAL VOLUME AT THE LAST 4 REFILLS WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME; THE DISCREPANCIES WERE WITHIN DEVICE SPECIFICATION LIMITS. THERE WERE NO MOTOR STALLS SHOWING IN THE LOGS. THE HCP PLANNED TO DO ADDITIONAL TROUBLESHOOTING. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID 20 MG/ML AND BUPIVACAINE 10 MG/ML. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 55 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8596SC, LOT# N108932006| CATHETER: MODEL 8703W, LOT# L38826| IMPLANTED:| EXPLANTED: