BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5068775 · Received September 10, 2015

    Report

    Report Number
    3007566237-2015-02563
    Event Type
    Injury
    Date Received
    September 10, 2015
    Report Date
    August 19, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1150-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8590-1, LOT# N152935, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM AN MRI TECHNOLOGIST REGARDING THE DELIVERY OF UNKNOWN MORPHINE (DOSE AND CONCENTRATION WERE UNKNOWN) IN AN IMPLANTABLE INFUSION PUMP FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. THE PATIENT WAS DIAGNOSED WITH AN INFLAMMATORY MASS/GRANULOMA IN 2010. TO THE KNOWLEDGE OF THE MRI TECHNICIAN, THE PATIENT HAD A HISTORY OF GRANULOMA. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE HEALTHCARE PROVIDER (HCP) REGARDING DRUG INFORMATION AT THE TIME OF THE EVENT, CONCOMITANT DRUG INFORMATION, PERTINENT MEDICAL HISTORY, PATIENT SYMPTOMS EXPERIENCED, ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE ISSUE, AND IF THE CAUSE OF THE ISSUE WAS DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597954 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Other