BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1232343 · Received November 13, 2008

    Report

    Report Number
    2182207-2008-07422
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 15, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT INTO AN OVERDOSE SITUATION FOLLOWING A NEW PUMP AND CATHETER IMPLANT. SPECIFIC SYMPTOMS WERE NOT PROVIDED. THE HEALTH CARE PROFESSIONAL STATED THAT THE PRIMING VOLUME WAS 1799 ML AND THE TOTAL PRIME VOLUME SHOULD HAVE BEEN 0.428ML; THE CONCENTRATION WAS 500 MCG/ML. THE PATIENT WAS STABLE AND BEING CLOSELY MONITORED. UNABLE TO FOLLOW-UP WITH CONTACT INFORMATION PROVIDED, NO ADDITIONAL INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL CATHETER| PROGRAMMER: MODEL 8840