BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3833677 · Received May 27, 2014

    Report

    Report Number
    3007566237-2014-01440
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT TOLD THE HEALTH CARE PROVIDER (HCP) THAT HER PUMP WAS ¿NOT WORKING¿ AND WAS ALARMING EVERY THREE MINUTES. AN MRI WAS TO BE PERFORMED HOWEVER IT WAS CONFIRMED TO NOT BE RELATED TO THE PUMP. THE TYPE OF MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT PROVIDED. NO FURTHER INFORMATION WAS 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
    310465 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR