BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW PROFILE EXTENSION

    MDR report key: 1902194 · Received November 15, 2010

    Report

    Report Number
    3007566237-2010-09553
    Event Type
    Injury
    Date Received
    November 15, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 9, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EXTENSION ON THE RIGHT SIDE WAS EXPOSED, ALTHOUGH THERE WAS NO PUS. THE PT DIDN'T FEEL UNCOMFORTABLE. THE EXTENSION WAS REPLACED ON (B)(6) 2010. ADDITIONAL INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW PROFILE EXTENSION MHY MEDTRONIC NEUROMODULATION 7482 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention