BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 16194345 · Received January 18, 2023

    Report

    Report Number
    3006630150-2023-00101
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    December 27, 2022
    Report Date
    February 27, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT:PRODUCT FAMILY: DBS-LINEAR LEADS.UPN: M365DB2202450.MODEL: DB-2202-45.SERIAL: (B)(6). BATCH: 7094858.PRODUCT FAMILY: DBS-LINEAR LEADS.UPN: M365DB2202450.MODEL: DB-2202-45.SERIAL: (B)(6). BATCH: 7094860. PRODUCT FAMILY: DBS-EXTENSION.UPN: M365NM3138550.MODEL: NM-3138-55.SERIAL: (B)(6).BATCH: 7102392.PRODUCT FAMILY: DBS-EXTENSION.UPN: M365NM3138550.MODEL: NM-3138-55.SERIAL: (B)(6).BATCH: 7102404.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7094858; PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7094860; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7102392; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7102404.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT'S DEEP BRAIN STIMULATION SYSTEM WAS EXPLANTED DUE TO AN INFECTION AT THE IPG POCKET SITE. THE PATIENT WAS PLACED ON ANTIBIOTICS BEFORE THE EXPLANT PROCEDURE. THE PATIENT HAS FULLY RECOVERED FOLLOWING THE PROCEDURE. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO BSC FOR ANALYSIS AS THEY WERE KEPT BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION RECEIVED ON 17FEB2023 INDICATES THAT THE PATIENT WAS EXPERIENCING HEAT, DISCHARGE, SWELLING, AND REDNESS AT THE POCKET SITE. THE PHYSICIAN BELIEVES THE INFECTION IS PROCEDURE RELATED AND NOT DEVICE RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT'S DEEP BRAIN STIMULATION SYSTEM WAS EXPLANTED DUE TO AN INFECTION AT THE IPG POCKET SITE. THE PATIENT WAS PLACED ON ANTIBIOTICS BEFORE THE EXPLANT PROCEDURE. THE PATIENT HAS FULLY RECOVERED FOLLOWING THE PROCEDURE. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO BSC FOR ANALYSIS AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820951 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1416 210502 08714729985020

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention