BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2210500 · Received August 10, 2011

    Report

    Report Number
    3004209178-2011-06209
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PUMP ALARMED ON (B)(6) 2011 AND A CRITICAL ALARM WAS CONFIRMED BY TELEMETRY. IT WAS DUE TO A MOTOR STALL. WHEN INTERROGATED ON (B)(6) 2011 DURING THE REFILL SESSION THE PUMP WAS IN MIN RATE MODE. THE EVENT LOGS SHOWED A LOW BATTERY AND RESET HAD OCCURRED (B)(6) 2011 WITH A MOTOR STALL ON (B)(6) 2011. IT WAS ALSO NOTED THAT THE OLDEST EVENT LOG ENTRY SHOWED A MOTOR STALL RECOVERY OF (B)(6) 2011. THE PUMP WAS UPDATED WITH THE RESERVOIR VOLUME AND PUT BACK IN S.C. MODE. ON (B)(6) 2011 THE PATIENT PRESENTED TO THE CLINIC WITH A STOPPED PUMP MODE, MOTOR STALL, RESET AND SAFE STATE. THE DRUG DELIVERED WAS FENTANYL 1500 MCG/ML AT 425 MCG/DAY. THE PUMP WAS SET IN MINIMUM RATE AND LATER REPLACED; THE CAUSE WAS STATED AS BATTERY DEPLETION. GOOD CSF (CEREBROSPINAL FLUID) RETURN THROUGH CATHETER WAS NOTED. PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N181455008