BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3061395 · Received April 16, 2013

    Report

    Report Number
    3007566237-2013-01299
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 17, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND ALTERED MENTAL STATUS AND PAIN AND HAD BECOME "HARD TO AROUSE" AND UNRESPONSIVE. THE PATIENT WAS HOSPITALIZED. THE PUMP WAS INTERROGATED, THE DOSING AND LOGS WERE CHECKED AND APPEARED TO BE RUNNING CORRECTLY. THE FOLLOWING DAY THE HEALTHCARE PROVIDER (HCP) INDICATED THAT THE PATIENT "SEEMED MORE EASILY AROUSED." THE FOLLOWING PHYSICIAN WAS MADE AWARE OF THE EVENT. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL. IT WAS LATER ADDED THAT THE PATIENT HAD BEEN REFERRED TO A NEUROLOGIST. THE PUMP WAS RUNNING "FINE" AND THE PATIENT WAS FOLLOWING UP WITH THE MANAGING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162433 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization