BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERCISE GENUS

    MDR report key: 17322902 · Received July 14, 2023

    Report

    Report Number
    3006630150-2023-04113
    Event Type
    Death
    Date Received
    July 14, 2023
    Date of Event
    June 22, 2023
    Report Date
    July 14, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, 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: 7102791. PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7102956. PRODUCT FAMILY: DBS-LEAD FIXATION: UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: NA, BATCH: 30994076. PRODUCT FAMILY: DBS-EXTENSION: UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7106508. PRODUCT FAMILY: DBS-EXTENSION: UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7110248.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED PNEUMONIA SHORTLY AFTER THE STAGE TWO DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE. ALTHOUGH SHE SEEMED TO HAVE RECOVERED, SHE LATER RETURNED TO THE HOSPITAL WHERE THE PHYSICIAN ASSESSED HER TO BE SUFFERING FROM SEPTIC SHOCK. THE PATIENT PASSED AWAY SHORTLY THEREAFTER. THE PHYSICIAN ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207670 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 554181 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Death