BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1162246 · Received September 16, 2008

    Report

    Report Number
    2182207-2008-05806
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 20, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING PUMP REPLACEMENT AND CATHETER REVISION, THE PATIENT DEVELOPED A SEROMA AND CEREBROSPINAL FLUID (CSF) LEAK. FLUID WAS PULLED OUT OF THE POCKET AND TESTED POSITIVE FOR CSF. THE PATIENT ALSO EXPERIENCED RETURN OF SYMPTOMS WITH INCREASED BASELINE PAIN AND SWELLING OVER THE POCKET. NO ALARM WERES NOTED. A VOLUME DISCREPANCY GREATER THAN 25% WAS NOTED. THE EXPECTED RESERVOIR VOLUME WAS 1.6ML; THE ACTUAL RESERVOIR VOLUME WAS 40ML. NO DIAGNOSTIC STUDIES HAD BEEN PERFORMED. THE PHYSICIAN WAS PLANNING TO PERFORM A ROLLER STUDY. THE PATIENT'S PUMP CONTAINED BACLOFEN AND MORPHINE. 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 60 YR Required Intervention CATHETER: MODEL 8709| PROGRAMMER: MODEL 8840| EXPLANTED :| EXPLANTED:| CATHETER: MODEL 8596SC