BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 3860120 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01521
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    March 18, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH A DEEP BRAIN STIMULATION DEVICE PRODUCED ARTIFACT ON THE PATIENT'S PACEMAKER. THE PATIENT WAS NOTED NOT TO BE PACEMAKER DEPENDENT. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE PHYSICIAN INDICATED THAT THE PATIENT COULD "MISS BEATS" OR SUPPRESS PACING BECAUSE OF THE INTERFERENCE. THE PHYSICIAN INDICATED THAT THIS WAS NOT LIFE THREATENING AT THIS TIME BECAUSE THE PATIENT'S HEART CAN "PICK UP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339969 PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1