BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1230548 · Received November 13, 2008

    Report

    Report Number
    2182207-2008-07428
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 17, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED NAUSEA AND WAS "TIGHTER". INTERROGATION REVEALED A MOTOR STALL HAD OCCURRED IN 2008 AT 0718. NO RECOVERY WAS NOTED. THERE WAS NO MRI OR EMI EXPOSURE. A THERAPEUTIC BOLUS OF 25 MCG WAS PROGRAMMED AND THE PUMP WAS UPDATED, BUT THE PATIENT DIDN'T SHOW A RESPONSE TO THE BOLUS. THE PUMP WAS AGAIN INTERROGATED AND NO STALL RECOVERY WAS NOTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND MANAGED UNTIL THE PUMP WAS REPLACED. NO ROTOR OR CATHETER DYE STUDY WAS PERFORMED. THE PATIENT RECOVERED WITHOUT SEQUELA. THE PATIENT'S PUMP CONTAINED LIORESAL 2000 MCG/ML AT A DOSE OF 620 MCG/DAY.

    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 9 YR Required Intervention CATHETER: MODEL 8731| PROGRAMMER: MODEL 8840| EXPLANTED:| IMPLANTED: