BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3002316 · Received March 13, 2013

    Report

    Report Number
    3007566237-2013-00769
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, CATHETER MODEL 8703W, LOT # L36765, IMPLANTED: (B)(6) 1995. (B)(4) -VERY BAD TASTE IN MOUTH, SAME IN THE NOSE; (B)(4) "PUMP'S NOT WORKING CONSISTENTLY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED "INTERMITTENT WITHDRAWALS," A "VERY BAD TASTE IN MOUTH, SAME IN THE NOSE; RUNNING, WATER, ITCHY EYES, LOOSE BOWELS, THROWING UP." PATIENT WAS SEEN IN THE EMERGENCY DEPARTMENT 3 DAYS PRIOR TO THE INITIAL REPORT WITH THE ABOVE SYMPTOMS AND RECEIVED "A SHOT," OF WHAT WAS NOT REPORTED. IT WAS NOTED THAT THE PUMP WAS "NOT WORKING CONSISTENTLY." THE PATIENT WAS SEEN IN CLINIC THE DAY OF THE INITIAL REPORT, NO ALARMS WERE HEARD, PUMP LOGS READ- NO ALARMS, PROGRAMMING WAS CORRECT. THE NEXT DAY IT WAS REPORTED THAT THE RESERVOIR VOLUME WAS CHECKED, NO VALUES WERE REPORTED. THREE WEEKS AFTER THE INITIAL REPORT, IT WAS NOTED THAT A CATHETER DYE STUDY WAS DONE ON (B)(6) 2013 WITH "NO EVIDENCE OF DISRUPTION OF THE CATHETER OR BLOCKAGE." PATIENT HAD BEEN REFERRED TO NEUROSURGEON. THE DEVICE SYSTEM WAS USED TO INFUSE DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105200 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1