BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202365 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-00124
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    March 8, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, LOT# N234555, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE (B)(6) 2010 THE PATIENT HAD A DECREASE IN THERAPEUTIC EFFECT. IT WAS NOTED THAT ALL OF A SUDDEN EFFICACY WAS LOST WHEN THE MEDICATION WAS SWITCHED FROM A LOW DOSE TO A HIGH DOSE MEDICATION. THE THERAPY NEVER REALLY GOT BACK TO WHERE IT WAS. THE DOSING WAS ¿PLAYED WITH.¿ THE DOSE WAS RAISED UP A BIT, AND THE PATIENT WAS ¿GOOD¿ FOR A COUPLE OF DAYS BEFORE LOSING EFFECT AGAIN. THE PUMP WAS ¿CLEANED OUT¿ WITH SALINE ON (B)(6) 2011 AND A LOWER DOSE MEDICATION WAS PUT BACK IN THE PUMP. THE PROBLEM PERSISTED. A CATHETER DYE STUDY WAS PERFORMED ON (B)(6) 2012--THE SECOND ONE IN A YEAR¿AND IT WAS FOUND THAT THE CATHETER HAD A LOOP IN IT. IT WAS NOTED THAT IT WAS WITHIN NORMAL LIMITS AND DID NOT LEAK. IT WAS THOUGHT THAT THERE WAS A POSSIBILITY THAT THE CATHETER SLIPPED AND SLID DOWN THE SPINE A LITTLE BIT. THE PATIENT ALSO HAD A MAGNETIC RESONANCE IMAGING SCAN ON (B)(6) 2012, BUT THE RESULTS WERE NEGATIVE. IT WAS ALSO NOTED THAT THE LOSS OF EFFICACY MAY BE DUE TO THE PATIENT¿S DISEASE PROGRESSION. IT WAS ALSO REPORTED THAT THE PATIENT HEARD A TICKING SOUND COMING FROM THE PUMP. THE DRUG IN THE PUMP WAS LIORESAL (BACLOFEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301860 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR