BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6394716 · Received March 10, 2017

    Report

    Report Number
    3004209178-2017-05382
    Event Type
    Injury
    Date Received
    March 10, 2017
    Report Date
    March 10, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100824
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. 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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING BACLOFEN 2000MCG/ML AT 2100MCG/DAY VIA AN IMPLANTABLE PUMP. THE INDICATIONS FOR USE WERE INTRACTABLE SPASTICITY AND MULTIPLE SCLEROSIS. A CATHETER DYE STUDY WAS PERFORMED TODAY (B)(6) 2017 AND THE HEALTHCARE PROVIDER WAS UNABLE TO ASPIRATE THE CATHETER. PER THIS REPORTER THE PATIENT¿S PUMP HAS HAD ISSUES WITH VOLUME DISCREPANCIES IN THE PAST. IT WAS NOTED THAT THE REPORTER HAD RECEIVED CONFLICTING INFORMATION ABOUT WHETHER THEY WERE GETTING MORE OR LESS BACK THAN EXPECTED FROM THE PUMP. THE PATIENT WAS EXPERIENCING SYMPTOMS OF STIFFNESS AT THE TIME AS WELL BUT THE REPORTER WAS NOT CERTAIN WHETHER IT WAS DUE TO THE VOLUME DISCREPANCY OR IF THE ISSUE WAS JUST PROGRESSING. THE LOGS WERE READ AND THERE WERE NO MOTOR STALLS OR ALARMS THAT HAD OCCURRED. PER THE COMPANY REPRESENTATIVE THE HEALTHCARE PROVIDER WOULD BE REPLACING THE CATHETER AND POTENTIALLY THE PUMP AS WELL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177116 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169100824

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention