BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5258586 · Received December 1, 2015

    Report

    Report Number
    3004209178-2015-23618
    Event Type
    Malfunction
    Date Received
    December 1, 2015
    Report Date
    November 12, 2015
    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 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) .

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A (B)(6) MALE PATIENT RECEIVING 2000UG/ML GABLOFEN (BACLOFEN) (LOT 2163-113) AT 1440.7UG/DAY VIA AN INFUSION PUMP IMPLANTED FOR INTRACTABLE SPASTICITY AND POST SPINAL CORD INJURY. IT WAS REPORTED THAT AT A PUMP REFILL IN (B)(6) 2015 THE HCP WAS ABLE TO ASPIRATE THE RESERVOIR PROPERLY BUT WAS ONLY ABLE TO INJECT 38ML. THE REPORTER NOTED THAT BUBBLES WERE SEEN SO SHE WAS ¿CERTAIN SHE GOT ALL FLUID FROM THE PUMP.¿ THE HCP CONFIRMED THAT THE PATIENT HAD NOT BEEN EXPOSED TO HYPERBARIC OR SCUBA EQUIPMENT AND NO OFF-LABEL DRUGS WERE USED IN THE PUMP. THE HCP WHO HAD FILLED THE PUMP THE LAST TIME WAS ONLY ABLE TO INJECT 37ML (AROUND (B)(6) 2015). THE PATIENT¿S PUMP WAS REPORTEDLY REFILLED EVERY ONE AND A HALF MONTHS ¿OR SO.¿ NO SYMPTOMS WERE REPORTED. FOLLOW UP WAS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION REGARDING TROUBLESHOOTING PERFORMED RELATED TO THE DIFFICULTY FILLING, WHAT ACTIONS/ INTERVENTIONS WERE TAKEN TO RESOLVE THE ISSUE, THE CAUSE OF THE DIFFICULTY, AND WHETHER THE FILLING DIFFICULTY HAD BEEN RESOLVED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786866 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR