BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE

    MDR report key: 7332803 · Received March 12, 2018

    Report

    Report Number
    3006630150-2018-00996
    Event Type
    Injury
    Date Received
    March 12, 2018
    Date of Event
    April 10, 2017
    Report Date
    March 12, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729836490
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: DB-2201-30DC SERIAL #: (B)(4) DESCRIPTION: 30 CM TWIST LEAD, 0.016 TUNGSTEN STYLET MODEL #: NM-3138-55 SERIAL #: (B)(4), 1073209 DESCRIPTION:55 CM 8 CONTACT EXTENSION KIT THE DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS AND LEAD EXTENSIONS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WAS FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT BANGED HIS HEAD. SCABS AND AN INFECTION APPEARED AT THE LEAD INSERTION SITE OF THE CRANIAL LEADS. THE PATIENT WAS HOSPITALIZED AND RECEIVED IV ANTIBIOTICS STARTING ON 10-APR-2017, FOR 6 WEEKS. THE PATIENT THEN UNDERWENT AN EXPLANT PROCEDURE WHERE THE CRANIAL LEADS AND LEAD EXTENSIONS WERE REMOVED ON (B)(6) 2017. THE INFECTION HAS RESOLVED AND THE PATIENT IS DOING WELL. THE PHYSICIAN ASSESSED THAT THE INFECTION WAS NOT SEVERE AND IT IS UNKNOWN IF THE INFECTION WAS RELATED TO THE DEVICE OR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174006 VERCISE DEEP BRAIN STIMULATOR NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2201-30DC NA 08714729836490

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R