BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1162241 · Received September 16, 2008

    Report

    Report Number
    2182207-2008-05740
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Report Date
    August 20, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT EXPERIENCING ANY SYMPTOMS. THERE WERE TWO VOLUME DISCREPANCIES GREATER THAN 25%. AT FIRST REFILL THE EXPECTED RESERVOIR VOLUME WAS 28.5 ML, THE ACTUAL RESERVOIR VOLUME WAS 0ML. THE DRUG WAS THEN REPLACED WITH PRESERVATIVE FREE NORMAL SALINE. THE EXPECTED AND ACTUAL RESERVOIR VOLUMES WERE EQUAL AT THE SECOND REFILL. DRUG WAS THEN PUT BACK INTO THE PUMP. THE EXPECTED RESERVOIR VOLUME WAS 12.6 ML; THE ACTUAL RESERVOIR VOLUME WAS 0 ML. NO PATIENT TREATMENT OR OUTCOME WAS REPORTED. ADDITIONAL INFO 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 EXPLANTED:| CATHETER: MODEL 8709| PROGRAMMER: MODEL 8840