BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 2193633 · Received July 14, 2011

    Report

    Report Number
    3007566237-2011-05413
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Report Date
    June 21, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    HCP REPORTED THERE WAS "AN URGENT SITUATION WHERE THEY NEED TO REPLACE A PUMP." SEVERAL ATTEMPTS TO FOLLOW-UP WITH THE HCP FOR ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1