BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE®

    MDR report key: 3942596 · Received July 17, 2014

    Report

    Report Number
    3006630150-2014-01649
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE REPORTED IN THIS MDR FORM FALLS UNDER INVESTIGATIONAL DEVICE EXEMPTION (IDE) AND SHOULD NOT HAVE BEEN REPORTED ON A 3500A MDR FORM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT DYSARTHRIA WAS RESOLVED AND THE PATIENT HAD RECOVERED.

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 1942. EVENT DATE: (B)(6) 2013.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING GAIT SHUFFLING, DYSARTHRIA, AND IMPACTED ESOPHAGEAL FOOD BOLUS. IT WAS BELIEVED THAT THE EVENTS WERE RELATED TO THE DEVICE STIMULATION. THE PATIENT WAS PRESCRIBED MEDICATION FOR THE GAIT SHUFFLING AND THE EVENT WAS RESOLVED. THE PATIENT UNDERWENT AN ESOPHAGEAL BOLUS SECTION AND THE ESOPHAGEAL FOOD BOLUS WAS RESOLVED. THE PATIENT WAS TREATED WITH SPEECH THERAPY, BUT DYSARTHRIA WAS NOT RESOLVED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING GAIT SHUFFLING, DYSARTHRIA, AND IMPACTED ESOPHAGEAL FOOD BOLUS. IT WAS BELIEVED THAT THE EVENTS WERE RELATED TO THE DEVICE STIMULATION. THE PATIENT WAS PRESCRIBED MEDICATION FOR THE GAIT SHUFFLING AND THE EVENT WAS RESOLVED. THE PATIENT UNDERWENT AN ESOPHAGEAL BOLUS SECTION AND THE ESOPHAGEAL FOOD BOLUS WAS RESOLVED. THE PATIENT WAS TREATED WITH SPEECH THERAPY, BUT DYSARTHRIA WAS NOT RESOLVED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING GAIT SHUFFLING, DYSARTHRIA, AND IMPACTED ESOPHAGEAL FOOD BOLUS. IT WAS BELIEVED THAT THE EVENTS WERE RELATED TO THE DEVICE STIMULATION. THE PATIENT WAS PRESCRIBED MEDICATION FOR THE GAIT SHUFFLING AND THE EVENT WAS RESOLVED. THE PATIENT UNDERWENT AN ESOPHAGEAL BOLUS SECTION AND THE ESOPHAGEAL FOOD BOLUS WAS RESOLVED. THE PATIENT WAS TREATED WITH SPEECH THERAPY, BUT DYSARTHRIA WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418667 VERCISE® DEEP BRAIN STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION DB-1110C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention