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Recall Observatory FDA recall evidence

Device product

Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200

Z-1129-2022

March 30, 2022

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 89994
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-1129-2022

Official wording

Reason: The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.

Code information: Model: B35200; GTIN/UPN: 00763000420987; Serial number: NPI708734H; Expiration Date: 10/28/2022

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.