BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1823487 · Received August 25, 2010

    Report

    Report Number
    3007566237-2010-06405
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS NOT RESPONDING TO THE STIMULATION AND HAD A RETURN OF SYMPTOMS. THE PHYSICIAN SUSPECTED TO A DEVICE PROBLEM AND ON A F/U VISIT IMPEDANCE MEASUREMENTS WITH SOLETRA SHOWED >2000 OHMS. TEST WITH A EXTERNAL DEVICE SHOWED >18,000 OHMS ON ALL CONDUCTORS. THE LEAD WAS REPLACED AND THE PT WAS REPORTED AS "OKAY".

    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 Required Intervention EXPLANTED:| LEAD: MODEL 3389, LOT# UNK| IMPLANTED: