Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
- Company
- Medtronic Neuromodulation
- Recall Initiated
- March 30, 2022
- Recall Number
- Z-1129-2022
- Quantity
- 1 unit
- Firm Location
- Minneapolis, MN
Reason for Recall
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
Distribution
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.
Lot / Code Info
Model: B35200; GTIN/UPN: 00763000420987; Serial number: NPI708734H; Expiration Date: 10/28/2022
Root Cause
Under Investigation by firm
Action Taken
A customer letter, dated March 2022, was issued to the impacted consignee via mail. The consignee is instructed to ensure the patient programmer system is set up to communicate with the patient's INS at the patient's initial programming session. If a patient's INS cannot communicate with the clinician programmer and/or patient programmer system, and it is not possible to make therapy adjustments or turn stimulation off, the consignee should contact Medtronic Technical Services at 1-800-707-0933. The consignee is also asked to complete the customer confirmation form and submit to the recalling firm.