BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3800706 · Received May 8, 2014

    Report

    Report Number
    3007566237-2014-01280
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 16, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE CATHETER, PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2007-(B)(6), PRODUCT TYPE CATHETER. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN MRI OF THE PATIENT¿S NECK WAS TO BE PERFORMED AND THAT THE PUMP WAS ¿NOT WORKING¿ AND WOULD BE EXPLANTED. IT WAS ALSO NOTED THE PUMP WAS EMPTY. THE REPORTER HAD NO FURTHER INFORMATION. THE TYPE OF MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278802 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention