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Percept pc brainsense deep brain stimulation implantable neurostimulator
Official notice
11 Apr 2022
Last checked
11 Apr 2022
An official Health Canada notice concerns Percept pc brainsense deep brain stimulation implantable neurostimulator. Medtronic has determined that in rare instances (0.044%) the Percept™ PC implantable neurostimulator (INS) model B35200 cannot communicate with the clinician programmer and/or the patient programmer system (HH90 handset and TM91 communicator). In these instances, the INS will continue to provide therapy to the patient within programmed parameters. While the occurrence is rare, Medtronic is raising awareness to inform and serve our customers. Since the launch of Percept PC in January 2020 through the end of February 2022, Medtronic has received six (6) confirmed reports of this issue. Five (5) of these reported events occurred within the United States and one (1) event occurred in Switzerland. Two devices were explanted as a result of not being able to connect with the INS Medtronic can perform an ins diagnostic and communication reset should this issue occur and is investigating changes to prevent the occurrence. Recall start date: Mar 29, 2022 Published 2022-04-11.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64074
Official notice
2022-04-11
The hazard
The hazard
Medtronic has determined that in rare instances (0.044%) the Percept™ PC implantable neurostimulator (INS) model B35200 cannot communicate with the clinician programmer and/or the patient programmer system (HH90 handset and TM91 communicator). In these instances, the INS will continue to provide therapy to the patient within programmed parameters. While the occurrence is rare, Medtronic is raising awareness to inform and serve our customers. Since the launch of Percept PC in January 2020 through the end of February 2022, Medtronic has received six (6) confirmed reports of this issue. Five (5) of these reported events occurred within the United States and one (1) event occurred in Switzerland. Two devices were explanted as a result of not being able to connect with the INS Medtronic can perform an ins diagnostic and communication reset should this issue occur and is investigating changes to prevent the occurrence. Recall start date: Mar 29, 2022
How to check if you're affected
How to check if you're affected
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Brand: Medtronic, Percept Pc Brainsense Deep Brain Stimulation Implantable Neurostimulator.
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Documents, notices & source
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