BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 17624243 · Received August 25, 2023

    Report

    Report Number
    3006630150-2023-05067
    Event Type
    Injury
    Date Received
    August 25, 2023
    Date of Event
    July 27, 2023
    Report Date
    May 26, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7098337. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7098329. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7112181. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL:(B)(6). BATCH: 7111755.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7098337. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7098329. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7112181. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7111755.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A WOUND INFECTION OF THE LEFT DBS BATTERY AND CONNECTOR SITE. THE PATIENT WAS HOSPITALIZED. CULTURES WERE TAKEN AND WERE POSITIVE FOR INFECTION. ANTIBIOTICS WERE ADMINISTERED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE IPG, LEADS AND LEAD EXTENSIONS WERE REMOVED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EVENT WAS REPORTED AS RELATED TO THE DEVICE HARDWARE IPG, LEADS AND LEAD EXTENSIONS. ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATES THE RESULTS OF THE CULTURE TAKEN FROM THE PATIENT CAME BACK POSITIVE FOR MSSA AND THE SYMPTOMS CAUSED BY THE PATIENT'S INFECTION WERE PURULENT DRAINAGE AND ERYTHEMATOUS. IT WAS ALSO CONFIRMED THAT THE EXPLANTED DEVICES WERE DISCARDED AND WERE NOT RETURNED TO BSC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A WOUND INFECTION OF THE LEFT DBS BATTERY AND CONNECTOR SITE. THE PATIENT WAS HOSPITALIZED. CULTURES WERE TAKEN AND WERE POSITIVE FOR INFECTION. ANTIBIOTICS WERE ADMINISTERED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE IPG, LEADS AND LEAD EXTENSIONS WERE REMOVED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EVENT WAS REPORTED AS RELATED TO THE DEVICE HARDWARE IPG, LEADS AND LEAD EXTENSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372046 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 561794 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1