BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3172733 · Received June 17, 2013

    Report

    Report Number
    3007566237-2013-01996
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0591-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC FOR A PUMP REFILL AND THE HEALTHCARE PROVIDER (HCP) STATED THAT THE PUMP WAS ALARMING. THE ALARM WAS DETERMINED TO BE A CRITICAL ALARM. TELEMETRY SHOWED A MESSAGE OF ¿STOPPED PUMP, MOTOR STALL OCCURRED¿ ALONG WITH ¿MOTOR STALL RECOVERY¿ AND ¿PUMP RESTARTED¿. THE MOTOR STALL OCCURRED (B)(6) 2013 AT1300 AND STOP PUMP PERIOD ON (B)(6) 2013. THE PATIENT HAD AN MRI PERFORMED ON (B)(6) 2013. THE MOTOR STALL RECOVERY OCCURRED AT 11:46 ON THE DAY OF THE REPORT AND PUMP RESTART AT 11:29. THE PUMP WAS NOT UPDATED FOLLOWING THE MRI AND WENT INTO TELEMETRY STATE. INTERROGATION ON THE DAY OF THE REPORT RESTARTED THE PUMP. NO PATIENT SYMPTOMS WERE REPORTED. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273028 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR