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U.S. Department of Health and Human Services

Class 2 Device Recall Percept PC Implantable Neurostimulator (INS)

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  Class 2 Device Recall Percept PC Implantable Neurostimulator (INS) see related information
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
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
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
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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