BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3864203 · Received June 10, 2014

    Report

    Report Number
    3007566237-2014-01594
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8840, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PUMP WAS BEING UPDATED, THE PUMP WENT TO MINIMUM RATE MODE. THEY USED ANOTHER CLINICIAN PROGRAMMER WITH NO ISSUES. IT WAS NOT KNOWN WHEN THIS OCCURRED. THE SOFTWARE CARD WAS NOTED TO BE AAR 01. THE DRUG CONTAINED IN THE PUMP WAS UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN USED ANOTHER PHYSICIAN PROGRAMMER TO UPDATE THE PUMP. THERE WERE NO OTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338491 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1