BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3071551 · Received April 22, 2013

    Report

    Report Number
    3007566237-2013-01386
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    POURFAR, M., MOGILNER, A., MAMMIS, A., GOODMAN, R. A KERATOMA HORN FOLLOWING DEEP BRAIN STIMULATION. NEUROLOGY. 2013;80(7):688. SUMMARY: NEUROIMAGES- CAPTURES THE EVENT OF 2 PATIENTS WHOM THEY HAVE FOLLOWED WHO DEVELOPED A SLOWLY FORMING KERATOMA "HORN" AT THE CAP/WIRE JUNCTURE. REPORTED EVENT: 1 PATIENT DEVELOPED A SLOWLY FORMING KERATOMA AT THE CAP/WIRE JUNCTURE. THE PATIENT UNDERWENT SUCCESSFUL REMOVAL OF THE GROWTH FOLLOWED BY LESIONING OF THE VENTRALIS INTERMEDIUS AND REMOVAL OF THE DEEP BRAIN STIMULATION LEAD. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172206 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention