BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3122316 · Received May 21, 2013

    Report

    Report Number
    3007566237-2013-01691
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT ¿SUDDENLY¿ FELT ¿VERY SICK¿ TWO HOURS POST OPERATIVELY AFTER RECEIVING A REPLACEMENT PUMP. THE PHYSICIAN STOPPED THE PUMP AND IT WAS REPORTED THAT AFTERWARDS THE PATENT HAD ¿WITHDRAWAL SYNDROME.¿ IT WAS SAID THE DEVICE WAS REPROGRAMMED. THE OUTCOME WAS INDICATED AS ¿OVERDOSE SYMPTOMS¿. THE SYMPTOMS AND COMPLICATIONS WERE INDICATED AS BOTH ¿OVERDOSE SYMPTOMS¿ AND ¿UNDERDOSE SYMPTOMS.¿ THE PATIENT'S OUTCOME WAS SAID TO BE "DOING WELL". THE PUMP WAS DELIVERING MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224845 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention