BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5192876 · Received October 30, 2015

    Report

    Report Number
    3004209178-2015-21953
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Report Date
    October 9, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_PROG. PRODUCT TYPE: PROGRAMMER, PHYSICIAN. PRODUCT ID NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) IN CANADA REGARDING A PATIENT RECEIVING INTRATHECAL LIORESAL 1000 MCG/ML (DOSE 158.6 MCG/DAY) IN SIMPLE CONTINUOUS MODE VIA AN IMPLANTED PUMP. THE PATIENT'S MEDICAL HISTORY WAS NOT REPORTED. AROUND THE TIME OF POST PUMP REPLACEMENT ((B)(6) 2015) THE PATIENT HAD BEEN EXPERIENCING INCREASED SPASTICITY WITH A GRADUAL ONSET AND IT BECAME WORSE FROM 12AM TO 4PM. A PROGRAMMING MISTAKE HAD BEEN MADE WITH THE DOSING UNITS AT THE PUMP REPLACEMENT. NUMERICAL VALUES WERE CORRECT PER THE REPORTER. THE PATIENT HAD BEEN TRYING OTHER ORAL MEDICATIONS SO THEY WOULD ASSESS THOSE TO SEE IF THAT MAY BE THE CAUSE OF THE INCREASED SPASTICITY. THE CHANGE IN THERAPY/SYMPTOMS WAS GRADUAL. ON 10/13/2015, ADDITIONAL INFORMATION WAS RECEIVED FROM A HCP VIA A COMPANY REPRESENTATIVE (REP) INDICATED THEY WERE PLANNING ON BRINGING THE PATIENT BACK IN THIS WEEK FOR REPROGRAMMING TO CHANGE THE UNITS FROM "G/ML TO MCG/ML". THE MANAGING PHYSICIAN WOULD BE EVALUATING THE PATIENT AT THAT POINT TO TRY TO RESOLVE THE INCREASE IN SPASTICITY. ADDITIONAL INFORMATION WAS REQUESTED TO CLARIFY THE REPROGRAMMING CHANGE OF ""G/ML TO MCG/ML", HOW THE ISSUE WAS ULTIMATELY RESOLVED, INDICATIONS FOR USE, PATIENT OUTCOME, AND PROGRAMMER SERIAL. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ON 2015-11-24, ADDITIONAL INFORMATION WAS RECEIVED FROM THE FOREIGN MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THE HCP WAS CONCERNED THEY WERE USED TO USING "MCG/ML" INSTEAD OF "¿G/ML". ADDITIONAL CLARIFYING INFORMATION STATED THE DEVICE WAS PROGRAMMED TO "¿G/ML" IN ERROR AND SHOULD HAVE BEEN PROGRAMMED TO "MCG/ML". THE PUMP WAS ULTIMATELY PROGRAMMED TO "MCG/ML". THE ERROR IN PROGRAMMING DID NOT RESULT IN OVERDOSING OR UNDER-DOSING TO THE PATIENT BEFORE IT WAS RESOLVED. THE PROGRAMMING ERROR DID NOT REQUIRE HOSPITALIZATION OR SURGICAL INTERVENTION. THE INDICATION FOR USE FOR THE PUMP SYSTEM WAS SPASTICITY. THE PATIENT'S STATUS WAS REPORTED TO BE ALIVE AND WELL..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721831 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740

    Patients

    Seq Age Sex Outcome Treatment
    1