BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE®

    MDR report key: 4153439 · Received October 8, 2014

    Report

    Report Number
    3006630150-2014-02280
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 A FOLLOW UP COMPUTERIZED TOMOGRAPHY (CT) WAS TAKEN AND REVEALED THAT THERE WAS A DECREASED IN HEMORRHAGE ASSOCIATED WITH THE DBS ELECTRODE IN THE LEFT FRONTAL LOBE COMPARED TO THE PREVIOUS HEAD CT. THERE WAS NO OTHER EVIDENCE OF INFARCTION, HEMORRHAGE OR MASS EFFECT. THERE WAS STABLE POSITION OF BILATERAL DBS ELECTRODES TERMINATING NEAR SUBTHALAMIC NUCLEI. THE EVENT HAD RECOVERED. THE INVESTIGATOR REPORTED THE EVENT AS RELATED TO THE STUDY SURGICAL PROCEDURE AND STUDY DEVICE HARDWARE AND NOT RELATED TO THE STUDY DEVICE STIMULATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED INTRAOPERATIVE CEREBRAL HEMORRHAGE DURING LEAD REPLACEMENT. THE PATIENT WAS PROVIDED A MEDICATION. THE EVENT WAS PROCEDURE RELATED BUT NOT DEVICE STIMULATION OR DEVICE HARDWARE RELATED. THE EVENT WAS RESOLVING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED INTRAOPERATIVE CEREBRAL HEMORRHAGE DURING LEAD REPLACEMENT. THE PATIENT WAS PROVIDED A MEDICATION. THE EVENT WAS PROCEDURE RELATED BUT NOT DEVICE STIMULATION OR DEVICE HARDWARE RELATED. THE EVENT WAS RESOLVING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED INTRAOPERATIVE CEREBRAL HEMORRHAGE DURING LEAD REPLACEMENT. THE PATIENT WAS PROVIDED A MEDICATION. THE EVENT WAS PROCEDURE RELATED BUT NOT DEVICE STIMULATION OR DEVICE HARDWARE RELATED. THE EVENT WAS RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630878 VERCISE® DEEP BRAIN STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention