BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4221061 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20854
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 9, 2014
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD A REFILL ON THE DATE OF THE REPORT. 9 MILLILITERS (ML) WERE ASPIRATED, AND THEY EXPECTED 7.7 ML. THE PATIENT REPORTED A CHANGE IN THERAPY EFFECT, AND THEY HAD FELT MORE SPASTIC. THEY HAD WORSENING CALF CRAMPING, BACK PAIN, AND NECK PAIN. AN ALARM WAS HEARD, BUT TELEMETRY DID NOT CONFIRM AN ALARM. THE PATIENT REPORTED HEARING THE ALARM FOR A WEEK WHICH SOUNDED LIKE CHIRPS COMING FROM THE PUMP. ALARMS WERE PLAYED FOR THE PATIENT, AND THE PATIENT STATED THAT WAS NOT THE NOISE OR SOUNDS THEY WERE HEARING. THEY ALSO STATED THAT THE PUMP WAS MOBILE AND CHANGED BACK AND FORTH FROM THE ¿6 TO 8 O¿CLOCK POSITION¿. THE PUMP FELT A LITTLE MOBILE DURING THE REFILL, BUT IT DID NOT MOVE. THEY THOUGHT THAT MAYBE WHEN THE PUMP MOVED IT PINCHED THE CATHETER, AND WHEN IT MOVED BACK IT UN-PINCHED THE CATHETER. THE PATIENT¿S HEALTHCARE PROVIDER (HCP) REPORTED PUMP MOVEMENT IN THE POCKET WITH WEIGHT LOSS. THEY WERE TOLD TO WEAR AN ABDOMINAL BINDER IF IT WAS HELPFUL. THE PATIENT¿S DOSE WAS DECREASED AND THE PATIENT HAD DECREASED TONE. THE PATIENT MENTIONED NOT REMEMBERING THINGS VERY WELL AS THEIR MULTIPLE SCLEROSIS WAS PROGRESSING. THEY RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE PUMP CONTAINED GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702296 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR