BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201828 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11182
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 7, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER; PRODUCT ID 8578, LOT# N126907, IMPLANTED: (B)(6) 2008, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP MIGRATED APPROXIMATELY TWO WEEKS AGO AND A SURGICAL REVISION WAS PERFORMED TO REPOSITION THE PUMP. THE PATIENT WAS SUBSEQUENTLY EXPERIENCING BACLOFEN WITHDRAWAL. IT WAS THOUGHT THAT THE PUMP WAS NOT WORKING, BUT IT WAS NOTED THAT THE PUMP LOGS DID NOT INDICATE A MOTOR STALL, THUS IT WAS UNKNOWN WHAT WAS CAUSING THE WITHDRAWALS. THE PATIENT WAS LETHARGIC, NOT AWAKE AND COULD NOT MOVE. THEN IT WAS NOTED THE PATIENT HAD BEEN GIVEN ORAL BACLOFEN AND WAS NOTED THAT WAS WHAT RELAXED HER. THE PATIENT¿S FAMILY NOTED BEING ABLE TO HEAR A ¿TICK-TOCK¿ NOISE FROM THE PUMP, BUT NO LONGER HEARD THAT NOISE. IT WAS NOTED THE PUMP HAD NOT BEEN FILLED SINCE THE REVISION AND THE REFILL WAS DUE IN 8 DAYS FROM THE DATE OF THE REPORT. TROUBLESHOOTING OPTIONS WERE DISCUSSED. THE PUMP SYSTEM WAS BEING USED TO DELIVER BACLOFEN (COMPOUNDED). IT WAS LATER REPORTED THAT A ROTOR DYE STUDY WAS GOING TO BE PERFORMED. IT WAS LATER REPORTED THAT THE ROTOR DYE STUDY WAS NORMAL; THE ROLLERS MOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301097 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR Required Intervention