BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 7918039 · Received September 28, 2018

    Report

    Report Number
    3004209178-2018-21758
    Event Type
    Malfunction
    Date Received
    September 28, 2018
    Date of Event
    September 21, 2018
    Report Date
    September 28, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100831
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER; PHYSICIAN; PRODUCT ID: NEU_UNKNOWN_PROG, SERIAL/LOT #: UNKNOWN. 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) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING BA CLOFEN (1000MCG/ML AT 140MCG/DAY) VIA INTRATHECAL DRUG DELIVERY PUMP. THE INDICATION FOR USE WAS NOTED AS INTRACTABLE SPASTICITY AND MULTIPLE SCLEROSIS. IT WAS REPORTED THAT THE PATIENT HAD A REFILL OF THE PUMP ON (B)(6) 2018 (92 HOURS PRIOR TO THE REPORT) AND THE DRUG CONCENTRATION WAS CHANGED FROM 2000MCG/ML TO 1000MCG/ML, BUT THE HCP DID NOT CHANGE THE PROGRAMMING CONCENTRATION. THE CONCENTRATION WAS LEFT AT 2000MCG/ML AT 140MCG/DAY. THE PATIENT WAS BACK ON (B)(6) 2018 TO CORRECT THE PROGRAMMING. THE PATIENT WAS HAVING NO THERAPY ISSUES. THERE WERE NO FURTHER COMPLICATIONS REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758374 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169100831

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR