BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2853686 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11036
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 3, 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
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8840, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER; PHYSICIAN PRODUCT ID (B)(4), SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER; PRODUCT ID 8578, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED WITHDRAWAL THE EVENING AFTER HIS PUMP REPLACEMENT. THE PATIENT EXPERIENCED SYMPTOMS INCLUDE ITCHING, PAIN, INCREASED SPASMS AND SPASTICITY IN HIS HEAD, CALVES, NECK AND ABDOMEN. X-RAY PERFORMED ON (B)(6) 2012 SHOWED THAT THE CATHETER CONNECTOR APPEARED TO BE PROPERLY ALIGNED. THE DEVICE WAS REPROGRAMMED. A 50 MCG BOLUS WAS ORDERED PER MANAGING PHYSICIAN AS WELL AS A 15% INCREASE IN DAILY DOSE TO 700 MCG/DAY. APPROXIMATELY 30 MINUTES AFTER THE BOLUS, IT WAS NOTED THAT PATIENT'S "ITCHING HAD STOPPED" AND THE "SPASMS IN HIS ABDOMINAL WALL HAD DECREASED THOUGH THEY WERE STILL PRESENT." THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY OR ADVERSE EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD 80% IMPROVEMENT IN SYMPTOMS AND HE "FELT MUCH BETTER." THE DOCTOR TURNED THE RATE UP TO 750 MCG PER DAY. IT WAS NOTED THAT AN "ESTIMATED" CATHETER LENGTH WAS USED IN PROGRAMMING THE PRIMING BOLUS. IT WAS UNKNOWN IF THE EVENT WAS CAUSED BY THE UNDERESTIMATION OF THE ACTUAL CATHETER LENGTH. THE DEVICE WAS USED TO DELIVER BACLOFEN (LIORESAL).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR