BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1893199 · Received November 2, 2010

    Report

    Report Number
    3007566237-2010-08774
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 13, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT. THE LEAD HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL DISCOVERED THAT THE LEAD WAS CURVED WHEN IT WAS REMOVED FROM ITS PACKAGE. THE PT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3389 B0860554K

    Patients

    Seq Age Sex Outcome Treatment
    1