| Class 2 Device Recall Percept PC Implantable Neurostimulator (INS) | |
Date Initiated by Firm | November 19, 2020 |
Create Date | December 16, 2020 |
Recall Status1 |
Terminated 3 on April 03, 2023 |
Recall Number | Z-0612-2021 |
Recall Event ID |
86907 |
Product Classification |
Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
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Product | Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy. |
Code Information |
Model Number: B35200; GTIN: 00763000253363; Serial Numbers: NPI706941H, NPI707024H, NPI707000H, NPI706992H, NPI706963H, NPI706962H, NPI706987H, NPI706945H, NPI706952H, NPI706954H, NPI706955H, NPI706957H |
Recalling Firm/ Manufacturer |
Medtronic Neuromodulation 7000 Central Ave Ne Minneapolis MN 55432-3568
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For Additional Information Contact | David Young 800-707-0933 |
Manufacturer Reason for Recall | A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device. |
FDA Determined Cause 2 | Software design |
Action | Beginning November 19, 2020 accounts impacted by this issue were verbally notified to quarantine affected product.
Beginning November 25, 2020 a recall notification letter and retrieval instructions titled "URGENT: MEDICAL DEVICE RECALL A620 Patient Programmer issue with specific Percept" PC Neurostimulators" was hand delivered to impacted accounts by Medtronic Representatives. |
Quantity in Commerce | 12 devices |
Distribution | US Nationwide distribution including in the states of Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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