BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1001734 · Received February 19, 2008

    Report

    Report Number
    2182207-2008-00793
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 21, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PAIN PT'S PUMP STARTED TO ALARM. WHEN THE PUMP WAS INTERROGATED, IT SHOWED THAT THE ROTOR HAD STOPPED. THE HCP TRIED TO RESTART THE PUMP, BUT WAS UNSUCCESSFUL. THE NEXT DAY, A ROTOR STUDY WAS DONE AND SHOWED THE ROLLERS WERE NOT FUNCTIONING. NO PT SYMPTOMS WERE REPORTED. THE HCP REPLACED THE PUMP. THE PT OUTCOME WAS REPORTED AS "GOOD." THE DRUG BEING DELIVERED VIA THE PUMP WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention