BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3923583 · Received July 9, 2014

    Report

    Report Number
    3007566237-2014-01913
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8703W, LOT# L41861, IMPLANTED: (B)(6) 1997, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER DISCUSSING THE PATIENT'S NURSE FILLING THE PUMP THAT ONE TIME WHEN THE NURSE CAME THE PATIENT WAS UNRESPONSIVE AND THE NURSE CALLED AN AMBULANCE. THE EXACT DATE WAS UNKNOWN, BUT IT WAS THE BEGINNING OF 2002 OR 2003. IT WAS FURTHER REPORTED THEY THOUGHT THIS WAS HAPPENING BECAUSE THE NURSE ¿MISSED.¿ IT WAS NOTED ¿THEY PUT A DRUG IN HER BODY TO STOP THE PUMP.¿ IT WAS UNCLEAR WHAT WAS MEANT BY THIS. THE PUMP WAS BEING USED TO DELIVER MORPHINE, BUT THE DOSE AND CONCENTRATION WERE NOT SPECIFIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399756 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Required Intervention