BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1180989 · Received September 29, 2008

    Report

    Report Number
    2182207-2008-06202
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 31, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NOTED A PUMP ALARM WAS AUDIBLE AFTER A CT SCAN. THE PATIENT ALSO HAS A PACEMAKER. THE PATIENT WAS HOSPITALIZED FOR UNKNOWN REASONS. MULTIPLE CT SCANS AND OTHER TESTS HAD BEEN PERFORMED. A MOTOR STALL WAS NOTED; NO RECOVERY WAS NOTED. THE TELEMETRY STRIP NOTED THE FOLLOWING MESSAGE: "STOPPED PUMP PERIOD MAY EXCEED TUBE SET". THE HCP WAS CONSIDERING DEVICE TROUBLESHOOTING. THE PUMP CONTAINED FENTANYL 4.0 MG/ML AND BACLOFEN 300 MCG/ML. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, 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 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention PROGRAMMER: MODEL 8840| IMPLANTED:| CATHETER: MODEL 8731| EXPLANTED: