BEUDAMED
    FDA Recall Open, Classified

    Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320

    Recall: Z-1890-2024 · Initiated April 18, 2024

    Recall

    Recall Number
    Z-1890-2024
    Event Number
    94377
    Firm
    Boston Scientific Neuromodulation Corporation
    FEI Number
    3006630150
    Product Code
    NHL
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    April 18, 2024
    Posted
    May 24, 2024
    Address
    25155 Rye Canyon Loop, Valencia, CA, 91355-5004

    Description

    Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320

    Reason

    Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.

    Action

    On 4/18/24, correction notices were mailed to Physicians/Surgeons, Hospitals, Healthcare Professionals who were asked to do the following: 1) Review any patient reports of undesired sensations indicative of potential device reset behavior during IPG charging and report these observations accordingly to the firm. 2) After firm verifies this device reset behavior has occurred during IPG charging, an in-field IPG firmware update can be scheduled for the patient s device. This will eliminate the possibility of a coincident routine device system check during IPG charging, thus preventing a potential system reset. Any adverse events or quality concerns associated with use of this product should be reported to firm via email [email protected]

    Distribution

    Worldwide - US Nationwide distribution including in the states of TX, WA, MT, GA, TN, MA, OR, ID, CA, FL, WI, UT, DE, AZ, PA, DC, LA, KY, VA, MN, NC, OH, NY, MI, CO, IN, MD, NV, AL, IL, AR, SC, OK, MO, MS, NJ, ME, Hi, KS, SD, WV, NM, AK, CT, WY, NE, ND and the countries of Canada, Argentina, Chile, Colombia, Brazil, Algeria, Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Iceland, Ireland, Italy, Jordan, Kazakhstan, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, Australia, Thailand, Singapore, Hong Kong, Korea, India, Japan.

    Quantity

    14,977