BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3100245 · Received May 8, 2013

    Report

    Report Number
    3004209178-2013-07392
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT NO LONGER DESIRED TO BE TREATED WITH INTRATHECAL BACLOFEN AT THE TIME OF REPORT. THE PUMP HAD BEEN FILLED WITH SALINE AND PROGRAMMED TO THE LOWEST DELIVERY RATE SETTING. THERE HAD BEEN NO SURGICAL INTERVENTION, HOSPITALIZATION, OR PATIENT INJURY RELATED TO THE EVENT. THE DEVICE HAD PREVIOUSLY CONTAINED LIORESAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE MEDICATION IN THE PUMP HAD "RUN OUT". THE PATIENT WAS OUT OF TOWN FOR AN EXTENDED PERIOD OF TIME AND UNABLE TO FIND A PHYSICIAN TO REFILL THE PUMP. THE PUMP WAS ALARMING FOR ¿FOUR OR FIVE DAYS.¿ THE PATIENT WAS NOT FEELING ANY SIGNS OF WITHDRAWAL. THE PATIENT LATER STATED THEY DID NOT WISH TO HAVE THE PUMP REFILLED, BUT RATHER TO JUST HAVE THE ALARM SILENCED. THE PUMP WAS DELIVERING BACLOFEN, AND THE PATIENT STATED SHE HAD ORAL BACLOFEN AND MAGNESIUM. IT WAS CONFIRMED THAT ON (B)(6) 2013, THE PUMP WAS EMPTY. THE PATIENT DIDN¿T HAVE WITHDRAWAL SYMPTOMS AND WAS DOING ¿FINE¿ WITHOUT THE INTRATHECAL BACLOFEN. THE PUMP ALARM WAS EVENTUALLY SILENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201222 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1