BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 17858149 · Received October 2, 2023

    Report

    Report Number
    3006630150-2023-05979
    Event Type
    Injury
    Date Received
    October 2, 2023
    Date of Event
    July 18, 2023
    Report Date
    October 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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) LOT: 7091057 PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6) LOT: 7098889 PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6) LOT: 7108061 PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6) LOT: 7106355

    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). LOT: 7091057. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). LOT: 7098889. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). LOT: 7108061. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). LOT: 7106355.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE. THE CAUSE OF THE INFECTION WAS UNKNOWN AND THERE WERE NO SYMPTOMS. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND THE SYSTEM WAS EXPLANTED. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE. THE CAUSE OF THE INFECTION WAS UNKNOWN AND THERE WERE NO SYMPTOMS. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND THE SYSTEM WAS EXPLANTED. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761110 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1416 215497 08714729985020

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention