BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6212444 · Received December 29, 2016

    Report

    Report Number
    3004209178-2016-27395
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    December 24, 2016
    Report Date
    February 13, 2017
    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
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. 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

    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

    ANALYSIS OF THE PUMP ((B)(4) FOUND MOTOR GEAR TRAIN ANOMALIES; CORROSION AND/OR WEAR AND/OR LUBRICATION AND THE STALL WAS DUE TO GEAR WHEEL 3.

    Additional Manufacturer Narrative · 1

    THE PREVIOUSLY REPORTED (B)(4) NO LONGER APPLIES TO THIS EVENT. 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

    PMA/510(K) # UPDATED TO P860004.

    Additional Manufacturer Narrative · 1

    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 HEALTH CARE PROFESSIONAL VIA A REPRESENTATIVE REGARDING A PATIENT IN ARGENTINA WHO RECEIVED LIORESAL 2000 MCG/ML AT A DOSE OF 1,210.6 MCG/DAY. THE PATIENT CONCOMITANT MEDICATIONS WERE NOT OBTAINABLE AND THE MEDICAL HISTORY WAS UNKNOWN. IT WAS REPORTED THAT DURING NORMAL USE ON (B)(6) 2016 A MOTOR STALL HAD OCCURRED. THE LOGS FROM (B)(6) 2016 INDICATED THE MOTOR STALL OCCURRED ON (B)(6) 2016 AT 10:56 AND THE STOPPED PUMP PERIOD MAY EXCEED TUBE SET MESSAGE OCCURRED ON (B)(6) 2016 AT 10:56. THE PATIENT EXPERIENCED SYMPTOM RETURN INCLUDING SPASTICITY AND DYSTONIA. NO TROUBLESHOOTING, DIAGNOSTIC TESTING, INTERVENTIONS, OR ACTIONS WERE TAKEN. IT WAS UNKNOWN IF SURGICAL INTERVENTION WAS PLANNED. THERE WERE NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MIGHT HAVE LED OR CONTRIBUTED TO THE EVENT. AT THE TIME OF THE REPORT THE PUMP WAS IMPLANTED BUT REPORTED AS OUT-OF-SERVICE, THE ISSUE WAS NOT RESOLVED, AND THE PATIENT¿S STATUS WAS ALIVE-NO INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE IMPLANT DATE OF THE PUMP WAS (B)(6) 2012. THE PUMP HAD NOT RECOVERED FROM THE MOTOR STALL. THE HCP ORDERED A PUMP REPLACEMENT TO RESOLVE THE ISSUE. THE DATE OF THE EXPLANT WAS NOT AVAILABLE YET. THE PATIENT DID NOT REQUIRE HOSPITALIZATION. THE PATIENT WAS (B)(6) YEARS OLD AND WEIGHED (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PUMP HAD BEEN EXPLANTED ON (B)(6) 2017 AND WOULD BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864422 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention