BEUDAMED
    FDA Adverse Event Summary report: N

    ACTIVA

    MDR report key: 3082104 · Received April 15, 2013

    Report

    Report Number
    3082104
    Date Received
    April 15, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC INC.
    Product Code
    MHY
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT PLACEMENT OF BILATERAL DEEP BRAIN STIMULATORS TO HELP MANAGE SEVERE DYSTONIA. UNFORTUNATELY, THIS WORSENED HIS CONDITION AND EVENTUALLY HIS DEEP BRAIN STIMULATORS WERE TURNED OFF. PT HAS BEEN HAVING PROBLEMS WITH WOUND HEALING AT THE LEVEL OF HIS PULSE GENERATOR AND AFTER EXTENSIVE DISCUSSIONS WITH THE FAMILY AND WITH DISCUSSIONS WITH WOUND CARE, THE DECISION WAS MADE THAT HE WOULD BENEFIT FROM REMOVAL OF A PULSE GENERATOR AS WELL AS HIS LEADS INCLUDING THE CONNECTOR BETWEEN THE CRANIAL SEGMENT AND THE DISTAL SEGMENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162026 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR