BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2806941 · Received October 27, 2012

    Report

    Report Number
    3004209178-2012-09635
    Event Type
    Injury
    Date Received
    October 27, 2012
    Report Date
    September 28, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8703W, LOT# L37415, IMPLANTED: (B)(6) 1996, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PREVIOUSLY REPORTED EVENT [IT WAS NOTED A SIMILAR MOTOR STALL OCCURRENCE WAS PRESENT ON THE TELEMETRY REPORT BACK IN (B)(4) 2012. THE MOTOR STALL HAD RECOVERED AT THAT TIME HOWEVER] WAS PERTAINED TO MANUFACTURER REPORT # 3004209178-2012-02191. FROM THE VISITING NOTE ON (B)(4) 2012, PHQ-9 AND GAD-7 TESTS WERE DONE AND RESULTS SHOWED THE PATIENT HAD ¿20+ SEVERE DEPRESSION ISSUES AND 15+ SEVERE ANXIETY ISSUES.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MOTOR STALL WITH NO RECOVERY, THE PATIENT'S PUMP WAS SET TO MINIMUM RATE AND A PUMP REVISION WAS PLANNED. IT WAS REPORTED THAT THE PATIENT WENT TO THE HEALTHCARE PROVIDER'S (HCP) OFFICE ON (B)(6) 2012 DUE TO AN ALARMING PUMP. NO ALARMS WERE HEARD BY THE STAFF. IT WAS NOTED THAT THE PATIENT WAS LAST SEEN ON (B)(6) 2012 FOR A REFILL AND ON (B)(6) 2012 THERE WAS A DOSE ADJUSTMENT. TELEMETRY LATER SHOWED A MOTOR STALL ON (B)(6) 2012 @ 0057. PATIENT WAS SLEEPING AT THE TIME OF THE STALL, BUT HEARD THE CRITICAL ALARM. ANOTHER MESSAGE, "STOPPED PUMP PERIOD MAY EXCEED TUBE SET" OCCURRED ON (B)(6) 2012 AT 0057. IT WAS NOTED A SIMILAR MOTOR STALL OCCURRENCE WAS PRESENT ON THE TELEMETRY REPORT BACK IN (B)(6) 2012. THE MOTOR STALL HAD RECOVERED AT THAT TIME HOWEVER. ON (B)(6) 2012 THE PUMP WAS SET TO A MINIMUM RATE MODE, AND THE PATIENT WAS GIVEN ORAL MEDICATIONS TO COVER PAIN UNTIL TIME OF REPLACEMENT. THE PATIENT HAD FLU/COLD LIKE SYMPTOMS AFTER THE PUMP HAD BEEN PROGRAMMED TO MIN RATE MODE. SYMPTOMS INCLUDED HEADACHE, SNEEZING, AND LOWER BACK AND BILATERAL LOWER EXTREMITY PAIN. ON (B)(6) 2012, THE PUMP MOTOR STALL STILL HAD NO RECOVERY NOTED. THE HCP SILENCED THE AUDIBLE ALARMS AND REFERRED PATIENT TO A SURGICAL HCP FOR DEVICE REPLACEMENT. AS OF (B)(6) 2012, THE PUMP REMAINED STALLED AND IN MINIMUM RATE MODE, AND THE PATIENT WAS HAVING DIFFICULT PAIN CONTROL WITH CONTINUED ORAL MEDICATIONS. IT WAS LATER REPORTED THAT THE PATIENT HAD AN EVALUATION APPOINTMENT SET UP WITH THE SURGICAL HCP FOR PUMP REPLACEMENT TO TAKE PLACE IN 2013. THE MEDICATIONS IN THE PUMP WERE MORPHINE (COMPOUNDED), FENTANYL, AND CLONIDINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention