BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1973638 · Received January 18, 2011

    Report

    Report Number
    3007566237-2011-00442
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 1, 2010
    Report Date
    January 12, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A RETURN OF SYMPTOMS. THE ACTUAL RESIDUAL PUMP VOLUME WAS FOUND TO BE GREATER THAN THE EXPECTED RESIDUAL VOLUME. THE RESIDUAL VOLUME DISCREPANCIES SEEMED TO BE INCREASING OVERTIME. FOR THE LAST 6 REFILLS, THEY WERE OFF BY 3, 3.4, 3.7, 3.9, 4, AND 4.5 ML. THE PT SEEMED TO GET RELIEF FOR A FEW DAYS AND THEN THE EFFECT SEEMED TO DECREASE. A DYE STUDY WAS DONE AND FOUND TO BE NEGATIVE. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO 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 49 YR IMPLANTED:| CATHETER: MODEL 8709, LOT # N132178009| EXPLANTED: