BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3670430 · Received March 10, 2014

    Report

    Report Number
    3004209178-2014-04132
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Report Date
    February 12, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 8840, PRODUCT TYPE PROGRAMMER, PHYSICIAN. PRODUCT ID 8709, LOT# J10906R59, IMPLANTED: 2001-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN RECEIVING THE CORRECT DOSE SINCE IMPLANT. HOWEVER, SINCE IMPLANT, THE DOSING UNITS HAD BEEN LISTED AS MILLIGRAMS INSTEAD OF MICROGRAMS. THIS WAS NOT AFFECTING DOSING, AS THE LOW RATE WAS STILL WHAT WAS INTENDED. THERE WAS NO MEDICATION ERROR. THE HEALTHCARE PROVIDER (HCP) WAS PLANNING ON PROGRAMMING THE CORRECT DOSING UNTIL AT THE PATIENT¿S NEXT APPOINTMENT. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN 2000MCG/ML AT 401.5/DAY IN FLEX MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143283 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR