BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2100673 · Received May 12, 2011

    Report

    Report Number
    3007566237-2011-03448
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    July 1, 2009
    Report Date
    July 8, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION FROM THE PHYSICIAN REPORTING IMPEDANCE ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1