BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3021688 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04254
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8840, LOT # UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER; PRODUCT ID 8840, LOT # UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PUMP REFILL AND INTERROGATION, A "STOPPED PUMP" MESSAGE APPEARED. THE HEALTH CARE PROVIDER (HCP) ALSO TRIED A DIFFERENT PROGRAMMER ON THE PUMP. THE PUMP WAS RE-INTERROGATED AND WAS REPROGRAMMED TO THE APPROPRIATE FLEX MODE. THE HCP WAS NOT AWARE OF ANY ELECTROMAGNETIC INTERFERENCE (EMI) OR MOVEMENT OF THE TELEMETRY HEAD. THE PATIENT HAD NO SYMPTOMS. IT WAS NOTED THAT BECAUSE THE PATIENT GETS BOLUSES EVERY 3 HOURS, THE HCP WAS UNSURE IF THEY RECEIVED THEIR 2 PM BOLUS. THEY ALSO UPDATED THE PUMP TO THE CORRECT TIME, AS ONE OF THE PROGRAMMERS HAD THE INCORRECT TIME. THE PATIENT WAS NOTED TO BE DOING WELL. THE DRUG IN THE PUMP WAS GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124465 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR