BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 21735593 · Received March 31, 2025

    Report

    Report Number
    3006630150-2025-02032
    Event Type
    Injury
    Date Received
    March 31, 2025
    Date of Event
    February 5, 2025
    Report Date
    May 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRO CODE (PRODUCT CODE): MHY, NHL.

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE (PRODUCT CODE): MHY, NHL.

    Additional Manufacturer Narrative · 0

    CORRECTION TO BLOCKS B1, D4, H6. BLOCK D2B: PRO CODE (PRODUCT CODE): MHY, NHL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT ENCOUNTERED COMMUNICATION DIFFICULTIES BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE REMOTE; ADDITIONALLY, EXPERIENCING A LOSS OF STIMULATION RESULTING IN SLURRED SPEECH, HEADACHES, AND SHAKING. THE PHYSICIAN SUGGESTED THE REPORTED SYMPTOMS MAY BE RELATED TO NERVE DAMAGE; HOWEVER, IT WAS NOT SPECIFIED IF THE NERVE DAMAGE WAS RELATED TO THE DEVICE OR STIMULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT ENCOUNTERED COMMUNICATION DIFFICULTIES BETWEEN THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE REMOTE; ADDITIONALLY, EXPERIENCING A LOSS OF STIMULATION RESULTING IN SLURRED SPEECH, HEADACHES, AND SHAKING. THE PHYSICIAN SUGGESTED THE REPORTED SYMPTOMS MAY BE RELATED TO NERVE DAMAGE; HOWEVER, IT WAS NOT SPECIFIED IF THE NERVE DAMAGE WAS RELATED TO THE DEVICE OR STIMULATION. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT DID NOT EXPERIENCE ANY DIFFICULTY WITH REMOTE COMMUNICATION TO THE IPG. FURTHERMORE, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, THOUGH DETAILS REGARDING THE REASON FOR THE SCAN AND ITS RESULTS WERE NOT PROVIDED. THE PATIENT'S SLURRED SPEECH HAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED SLURRED SPEECH, HEADACHES, AND SHAKING, WHICH WERE INITIALLY ATTRIBUTED TO SUSPECTED COMMUNICATION DIFFICULTY BETWEEN THE REMOTE CONTROL (RC) AND THE IMPLANTABLE PULSE GENERATOR (IPG). SUBSEQUENT EVALUATION DETERMINED THAT THERE WERE NO COMMUNICATION ISSUES WITH THE DEVICE. INSTEAD, THE TREATING PHYSICIAN HAD DISABLED THE PATIENTS ABILITY TO ADJUST STIMULATION SETTINGS ON THE RC. THAT ISSUE WAS RESOLVED, AND THE PATIENTS SLURRED SPEECH DISSIPATED AND THE PATIENT REPORTED FEELING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529024 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 772662 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1