BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3163395 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10177
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 17, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AT THE PATIENT¿S REFILL, IT WAS SEEN THAT THE RESERVOIR CONTAINED 25ML OF DRUG WHEN THE PROGRAMMER STATED THAT IT SHOULD HAVE CONTAINED 5ML. IT WAS REPORTED THAT THE PATIENT WAS FINE WITH NO SYMPTOMS AND GREAT RELIEF. THE MANAGING PHYSICIAN WASN¿T TOO CONCERNED WITH THE DISCREPANCY AS HE SPECULATED THAT THE PUMP HAD BEEN FILLED WITH 40ML OF DRUG, BUT HAD ONLY BEEN PROGRAMMED AS 20ML. AT THE TIME OF REPORT, THE DRUG CONCENTRATION WAS BEING CHANGED AND THE PATIENT WAS UNDERGOING A BRIDGE BOLUS OVER AN 8 HOUR AND 3 MINUTE PERIOD. ABOUT TWO WEEKS LATER, IT WAS REPORTED THAT THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY. IT WAS NOTED THAT THERE HAD NOT BEEN AN EXPLANT. ABOUT TWO WEEKS AFTER THAT, IT WAS REPORTED THAT THE DEVICE WAS DELIVERING COMPOUNDED BACLOFEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS THE PUMP, BUT THE ISSUE WAS UNKNOWN. IT WAS STATED THAT THE ISSUE MAY HAVE BEEN DUE TO PROGRAMMING FROM THE TREATING REHABILITATION CENTER. THERE WAS NO PATIENT INJURY OR HOSPITALIZATION DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263652 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1