| Class 2 Device Recall Vercise Genus" R16 and R32 Implantable Pulse Generator Kit |  |
Date Initiated by Firm | April 18, 2024 |
Date Posted | May 24, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1890-2024 |
Recall Event ID |
94377 |
PMA Number | P150031 |
Product Classification |
Stimulator, electrical, implanted, for parkinsonian symptoms - Product Code NHL
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Product | Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320 |
Code Information |
REF/UDI-DI(GTIN)/Serial Number Range/Expiration Date Range:
M365DB12160/8714729985044/100209 - 753347/09-OCT-2020 through 26-MAR-2026;
M365DB12320/8714729985051/100104 - 753200/09-OCT-2020 through 21-MAR-2026 |
Recalling Firm/ Manufacturer |
Boston Scientific Neuromodulation Corporation 25155 Rye Canyon Loop Valencia CA 91355-5004
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For Additional Information Contact | Rebecca KinKead Rubio 651-581-0761 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | Device Design |
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 BSN.ComplaintCallCenter@bsci.com |
Quantity in Commerce | 14,977 |
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.
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Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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PMA Database | PMAs with Product Code = NHL
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