BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 17962468 · Received October 18, 2023

    Report

    Report Number
    3006630150-2023-06349
    Event Type
    Injury
    Date Received
    October 18, 2023
    Date of Event
    September 20, 2023
    Report Date
    December 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: UNKNOWN. MODEL: UNKNOWN. SERIAL: UNKNOWN. BATCH: UNKNOWN. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: UNKNOWN. MODEL: UNKNOWN. SERIAL: UNKNOWN. BATCH: UNKNOWN. PRODUCT FAMILY: DBS-EXTENSION. UPN: UNKNOWN. MODEL: UNKNOWN. SERIAL: UNKNOWN. BATCH: UNKNOWN. PRODUCT FAMILY: DBS-EXTENSION. UPN: UNKNOWN. MODEL: UNKNOWN. SERIAL: UNKNOWN. BATCH: UNKNOWN. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: N/A. BATCH: UNKNOWN.

    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: 7093703. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7093829. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7103264. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7103469. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: N/A. BATCH: 29661733.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE TO EXPLANT THE IMPLANTABLE PULSE GENERATOR (IPG) DUE TO AN INFECTION AT THE RIGHT CHEST POCKET. THE PATIENT ALSO EXPERIENCED PAIN AT THE SITE OF INFECTION AND WAS TREATED WITH ANTIBIOTICS. A CULTURE WAS PERFORMED AND CONFIRMED KLEBSIELLA AEROGENES, CUTIBACTERIUM ACNES, AND SERRATIA INFECTION. THE PATIENT IS DOING WELL POSTOPERATIVELY AND HAS HAD THEIR SUTURES REMOVED. THE PATIENT IS BEING TREATED WITH CEFEPIME INTRAVENOUSLY (IV). THE EXPLANTED IPG WAS RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE TO EXPLANT THE IMPLANTABLE PULSE GENERATOR (IPG) DUE TO AN INFECTION AT THE RIGHT CHEST POCKET. THE PATIENT ALSO EXPERIENCED PAIN AT THE SITE OF INFECTION AND WAS TREATED WITH ANTIBIOTICS. A CULTURE WAS PERFORMED AND CONFIRMED KLEBSIELLA AEROGENES, CURTIBACTERIUM ACNES, AND SERRATIA INFECTION. THE PATIENT IS DOING WELL POSTOPERATIVELY AND HAS HAD THEIR SUTURES REMOVED. THE PATIENT IS BEING TREATED WITH CEFEPIME INTRAVENOUSLY (IV). THE EXPLANTED IPG WAS RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD THE ENTIRE DBS SYSTEM EXPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE TO EXPLANT THE IMPLANTABLE PULSE GENERATOR (IPG) DUE TO AN INFECTION AT THE RIGHT CHEST POCKET. THE PATIENT ALSO EXPERIENCED PAIN AT THE SITE OF INFECTION AND WAS TREATED WITH ANTIBIOTICS. A CULTURE WAS PERFORMED AND CONFIRMED KLEBSIELLA AEROGENES, CURTIBACTERIUM ACNES, AND SERRATIA INFECTION. THE PATIENT IS DOING WELL POSTOPERATIVELY AND HAS HAD THEIR SUTURES REMOVED. THE PATIENT IS BEING TREATED WITH CEFEPIME INTRAVENOUSLY (IV). THE EXPLANTED IPG WAS RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89866 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 543222 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention