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Open, Classified

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

FDA Recall Z-1890-2024 · Posted 2024-05-24

Recalling FirmBoston Scientific Neuromodulation Corporation
Recall StatusOpen, Classified
Product CodeNHL
Date Initiated2024-04-18
Product Quantity14,977

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.

Firm 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]

Root Cause

Device Design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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