BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2845753 · Received November 26, 2012

    Report

    Report Number
    3007566237-2012-02833
    Event Type
    Injury
    Date Received
    November 26, 2012
    Report Date
    October 29, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2276-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED A LOW BATTERY RESET OF UNDETERMINED CAUSE. ALTHOUGH THIS BATTERIES INTERNAL RESISTANCE IS WITHIN SPECIFICATIONS, IT IS BELIEVED TO HAVE A HIGH RESISTANCE, WHICH CAN "COME AND GO." (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED WITHDRAWAL. THE PATIENT FELT COLD SWEAT, CHILLS AND SHAKINESS. THE PATIENT WENT TO THE URGENT CARE AND THOUGHT HE HAD SINUS ISSUES. THE ELECTIVE REPLACEMENT INDICATOR MESSAGE SHOWED IN THE LOGS. THE PATIENT BELIEVED THAT THE PUMP WAS AT END OF SERVICE. THE PATIENT HEARD A CRITICAL ALARM; TELEMETRY CONFIRMED A CRITICAL ALARM OCCURRED. SAFE STATE OCCURRED. THE PUMP LOGS SHOW SAFE STATE, LOW BATTERY RESET MESSAGES ON (B)(6) AT 1812. THE PATIENT PRESENTED TO THE EMERGENCY ROOM TO TRY TO GET ORAL MEDICATION UNTIL HE COULD GET BACK TO HIS HOME STATE FOR A PUMP REPLACEMENT. THE PATIENT WAS TRAVELING OUT OF STATE. THE PUMP WAS DELIVERING MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention