BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4132947 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18102
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 3, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP WAS RECENTLY REFILLED AND THE NURSE HAD JUST GOT A PHONE CALL FROM THE PATIENT'S FAMILY STATING THE PATIENT WAS COMPLAINING OF THE PUMP WAS MAKING A SOUND LIKE "TICKING." IT WAS REPORTED THAT THE PATIENT WAS GETTING GOOD THERAPY. THE PUMP WAS INFUSING LIORESAL. NO SYMPTOMS OR INTERVENTIONS WERE REPORTED. ADDITIONAL INFORMATION REPORTED THAT THE PUMP WAS ALARMING. THE CAUSE OF THE EVENT WAS UNKNOWN. THE PUMP WAS TURNED DOWN IN CASE MOTOR STALL RECOVERED. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR STALL WAS CONFIRMED IN THE EVENT LOGS WITH NO RECORDED RECOVERY. THE MOTOR STALL OCCURRED ON (B)(6) 2014 AND A STOP PUMP PERIOD MAY EXCEED A TUBE SET OCCURRED ON (B)(6) 2014. THE PATIENT WAS REPORTEDLY FINE AND HAD NO WITHDRAWAL OR SPASTICITY. THE PATIENT¿S LAST REFILL WAS ON (B)(6) 2014. SETTING THE PUMP TO MINIMUM RATE MODE WAS DISCUSSED. THE PUMP WAS USED TO DELIVER LIORESAL. NO INTERVENTION WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613303 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00014 YR