BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE®

    MDR report key: 3911326 · Received July 3, 2014

    Report

    Report Number
    3006630150-2014-01510
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    April 18, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED AN INCISIONAL LOCAL INFECTION OF THE STUDY DEVICE AND/OR THE TISSUE DIRECTLY ADJACENT TO THE STUDY DEVICE. A HEAD CT WITH AND WITHOUT CONTRAST WAS PERFORMED TO RULE OUT INTRACRANIAL INFECTION AND THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS. THE EVENT WAS RESOLVED. THE PHYSICIAN BELIEVED THE EVENT WAS NOT RELATED TO THE STUDY PROCEDURE AND RELATED TO THE STUDY DEVICE HARDWARE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED AN INCISIONAL LOCAL INFECTION OF THE STUDY DEVICE AND/OR THE TISSUE DIRECTLY ADJACENT TO THE STUDY DEVICE. A HEAD CT WITH AND WITHOUT CONTRAST WAS PERFORMED TO RULE OUT INTRACRANIAL INFECTION AND THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS. THE EVENT WAS RESOLVED. THE PHYSICIAN BELIEVED THE EVENT WAS NOT RELATED TO THE STUDY PROCEDURE AND RELATED TO THE STUDY DEVICE HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389694 VERCISE® DEEP BRAIN STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION DB-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R