BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2910955 · Received January 11, 2013

    Report

    Report Number
    3007566237-2013-00117
    Event Type
    Injury
    Date Received
    January 11, 2013
    Report Date
    December 18, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PATIENT PROGRAMMER: MODEL: 8835, SERIAL# UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE EVENT WAS UNKNOWN; HOWEVER, IT WAS NOTED THAT THIS WAS NON-PUMP RELATED. THE PATIENT OUTCOME WAS NOTATED AS AN ONGOING SERIOUS INJURY OR ILLNESS. THE DRUGS USED IN THIS SYSTEM WERE BUPIVACAINE, HYDROMORPHONE, AND FENTANYL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2012 AND HAD REPORTED SYMPTOMS OF FEVER, DROWSINESS AND WEAKNESS; "HE'S STILL VERY DROWSY, FALLING ASLEEP WHILE EATING, AROUSABLE, HE'S NOT STUPOROUS, HE'S NOT TO THAT POINT." HEALTHCARE PROVIDER WAS QUESTIONING IF PATIENT WAS "OVER MEDICATED/GOING INTO OVERDOSE." PUMP STATUS WAS NOT KNOWN AT THE TIME OF THIS REPORT EXCEPT THAT IT WAS UPDATED RECENTLY. DRUG DELIVERED VIA THE DEVICE WAS FENTANYL. 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
    17961 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization