BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 16598377 · Received March 23, 2023

    Report

    Report Number
    3006630150-2023-01489
    Event Type
    Injury
    Date Received
    March 23, 2023
    Date of Event
    January 12, 2023
    Report Date
    April 25, 2025
    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

    CORRECTION TO FIELD H10 - ADDITIONAL SUSPECT DEVICE UPDATED BASED ON ADDITIONAL INFORMATION RECEIVED ON 27MAR2023. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7093224.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: UNK-P-DBS-LINEAR_LEADS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED STIFFNESS AND TIGHTNESS CAUSING A REDUCTION IN THE PATIENT'S RANGE OF MOTION IN THE NECK AND CAUSING PAIN AND DISTRESS AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD AND THE IPG WERE REPOSITIONED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE LEAD WAS NOT REPOSITIONED AS INITIALLY REPORTED. THE IPG AND LEAD EXTENSION WERE REPOSITIONED DUE TO THE TIGHTNESS OF IPG EXTENSION WIRES. THE EVENT HAS RESOLVED, AND PATIENT HAS RECOVERED. THE RELATIONSHIP TO HARDWARE WAS REPORTED AS POSSIBLY RELATED TO THE IPG AND NOT RELATED TO STIMULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED STIFFNESS AND TIGHTNESS CAUSING A REDUCTION IN THE PATIENT'S RANGE OF MOTION IN THE NECK AND CAUSING PAIN AND DISTRESS AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD AND THE IPG WERE REPOSITIONED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED STIFFNESS AND TIGHTNESS CAUSING A REDUCTION IN THE PATIENT'S RANGE OF MOTION IN THE NECK AND CAUSING PAIN AND DISTRESS AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD AND THE IPG WERE REPOSITIONED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE LEAD WAS NOT REPOSITIONED AS INITIALLY REPORTED. THE IPG AND LEAD EXTENSION WERE REPOSITIONED DUE TO THE TIGHTNESS OF IPG EXTENSION WIRES. THE EVENT HAS RESOLVED, AND PATIENT HAS RECOVERED. THE RELATIONSHIP TO HARDWARE WAS REPORTED AS POSSIBLY RELATED TO THE IPG AND NOT RELATED TO STIMULATION. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE EVENT WAS POSSIBLY RELATED TO THE LEAD EXTENSION NOT THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362029 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 519418 08714729985044
    555682 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 519418 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention