Recall Z-1128-2022 ยท MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Medtronic Neuromodulation
Percept BrainSense Implantable Neurostimulator (INS), Model B35200
| Date | Mar 30, 2022 |
| Status | Open, Classified |
| Reason | The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 14164 units |
| 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 Arge |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.