BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2894949 · Received January 3, 2013

    Report

    Report Number
    3004209178-2013-00089
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 5, 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
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8731, LOT,# UNKNOWN, IMPLANTED/EXPLANTED: UNK. (B)(4) .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP HAD A CRITICAL ALARM AND SHOWED THE MESSAGE "MOTOR STALL PUMP MAY EXCEED TUBE SET"; HOWEVER PER REPORTER "THE CONTENT OF THE DRUG RESERVOIR KEPT DECREASING." IT WAS INDICATED THAT PATIENT WAS HOSPITALIZED DUE TO THE EVENT, BUT HAD EXPERIENCED NO SYMPTOMS/INJURIES. THERE WAS NO MRI DURING THIS PERIOD. PER THE PUMP LOGS THE MOTOR STALLED ON (B)(6) 2012 WITH NO RECOVERY AND LATER THE TUBE SET WARNING MESSAGE APPEARED ON (B)(6) 2012. DRUGS DELIVERED VIA THE DEVICE WERE NAROPIN AND MORPHINE. IT WAS LATER REPORTED THAT THE DEVICE EXPLANT WAS PLANNED BUT WAS NOT TO BE DONE YET BECAUSE THE PATIENT HAD CARDIAC ISSUES (NOT RELATED TO THE DEVICE SYSTEM). IT WAS ADDED THAT THE PUMP MAY BE REPLACED WHEN PATIENT GETS BETTER WITH HER CARDIAC ISSUE. A TEST TO CHECK THE FUNCTION OF THE PUMP SHOULD BE PERFORMED SOON. PER REPORTER PATIENT CONTINUED TO NOT FEEL PAIN AT THE MOMENT, "SO INFUSION MIGHT BE STILL GOING ON." A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2231 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization