BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERCISE GENUS

    MDR report key: 14762882 · Received June 21, 2022

    Report

    Report Number
    3006630150-2022-03046
    Event Type
    Death
    Date Received
    June 21, 2022
    Date of Event
    May 15, 2022
    Report Date
    June 21, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL/LOT: (B)(4); BATCH: 7090041. PRODUCT FAMILY: UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL/LOT: (B)(4); BATCH: 7090858. PRODUCT FAMILY: UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL/LOT: (B)(4); BATCH: 7096042. PRODUCT FAMILY: UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL/LOT: (B)(4); BATCH: 7097933.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATOR PATIENT REMAINED IN THE HOSPITAL POST LEAD IMPLANT PROCEDURE AS HE WAS EXPERIENCING CONFUSION. THE CONFUSION LATER IMPROVED AND THE PATIENT PROCEEDED WITH IMPLANT OF THE IMPLANTABLE PULSE GENERATOR AND LEAD EXTENSIONS. THE PATIENT WAS RELEASED TO A REHABILITATION FACILITY WHERE HE WAS REPORTEDLY FUNCTIONING AND SPEAKING, HOWEVER WAS UNRESPONSIVE AT SOME POINT LATER AND PASSED AWAY. THE PHYSICIAN'S NEUROLOGIST REPORTED THAT THE PATIENT'S SURGEON DID NOT BELIEVE THE DEATH WAS RELATED TO THE SURGERY. AN AUTOPSY WILL BE PERFORMED, BUT IT IS UNKNOWN IF THE RESULTS WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611687 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 528687 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death| H