Boston Scientific is recalling approximately 14,977 Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generators because the devices may experience a system check error during charging that causes the unit to reset. This reset can lead to a sudden loss of stimulation therapy for patients with movement disorders, potentially causing the return of severe symptoms or undesired physical sensations. Patients affected by this issue may require surgical intervention to replace or revise the implanted device. Identifying information includes model numbers M365DB12160 and M365DB12320 with expiration dates ranging from October 2020 through March 2026.
A routine system check triggered during battery charging can cause the pulse generator to reset, stopping the delivery of electrical stimulation to the brain. This sudden loss of therapy can cause a rapid worsening of movement disorder symptoms and may result in the patient requiring surgery to replace the faulty implant.
Healthcare provider consultation and potential surgical revision.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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