BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6001455 · Received October 5, 2016

    Report

    Report Number
    3004209178-2016-20499
    Event Type
    Injury
    Date Received
    October 5, 2016
    Report Date
    November 18, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1579-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS RECEIVED, THE PUMP RESERVOIR HAD 2 ML OF FLUID AND THE PUMP WAS RUNNING IN THE SIMPLE CONTINUOUS INFUSION MODE. THE PUMP WAS STALLED AS RECEIVED. THE PUMP MOTOR STALL RECOVERED DURING INTERNAL DECONTAMINATION AND MOTOR FUNCTION TESTING. IT WAS DISCOVERED DURING DISPENSE TESTING THAT THE COMPUTER RUNNING THE DISPENSE TESTING SOFTWARE HAD A DEFECTIVE DAQ CARD. THIS CARD CONTROLS THE VOLTAGE FOR THE PRESSURE SENSING TRANSDUCERS. THIS ISSUE WAS NOT LIMITED TO ONE TRANSDUCER; ALL THE TRANSDUCERS WERE AFFECTED. THE INITIAL TEST IS A THROW OUT TEST; RETEST IS ALLOWED PER RPA PROCESS. PUMP PASSED DISPENSE ACCURACY TESTING. DESTRUCTIVE ANALYSIS REVEALED A FEEDTHROUGH ANOMALY CAUSING THE REPEATED MOTOR STALLS AND MOTOR STALL RECOVERIES.

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS DELIVERING HYDROMORPHONE 4.0 MG/ML AT 1.3289 MG/DAY AND CLONIDINE 200.0 MCG/ML AT 66.45 MCG/DAY.

    Additional Manufacturer Narrative · 1

    RECENT FDA CODING CHANGES OFFER LIMITED OPTIONS FOR MEDICAL DEVICE EVALUATION CONCLUSION CODING. MEDTRONIC SELECTED CONCLUSION CODE BECAUSE, ALTHOUGH THE DEVICE MEETS DESIGN SPECIFICATION, CORRECTIVE ACTIONS ARE FOCUSED ON ENHANCEMENTS TO THE DESIGN MAKING THIS THE CLOSEST CODE AVAILABLE WITH RESPECT TO THIS EVENT.

    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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS RECEIVING AN UNKNOWN DRUG AT AN UNKNOWN CONCENTRATION AND DOSAGE VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN. ON (B)(6) 2016, IT WAS REPORTED THAT A PUMP REPLACEMENT WAS GOING TO OCCUR ON (B)(6) 2016 BECAUSE THE PUMP KEPT STALLING. NO PATIENT SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE (REP) INDICATED IT WAS UNKNOWN WHEN THE PATIENT FIRST STARTED TO EXPERIENCE THE MOTOR STALLS. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS RELATED TO THE MOTOR STALLS. TROUBLESHOOTING WAS NOT PERFORMED AND THE CAUSE WAS UNKNOWN. THE PUMP WOULD BE RETURNED. FURTHER INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652995 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention