Percept PC DBS implantable neurostimulator (2021-03-16)

Starting date:

March 16, 2021

Posting date:

April 8, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-75335

Last updated:
2021-04-08

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  Reason
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  Affected products

Affected Products 

Percept PC DBS implantable neurostimulator

Reason

Notification to inform customers of a potential issue with the stimulation cycling setting when using the INS replacement feature on the A610 clinician programmer application version 2.0.4584, 2.0.4594, 2.0.4605. When replacing an INS and using the A610 "Replacement" workflow to transfer existing neurostimulator settings to the new neurostimulator, cycling may appear to be enabled but cycling is actually disabled. This issue can only occur when using the A610 "Replacement" workflow. For all current patients who have a replacement model B35200 Percept PC INS with cycling enabled, list of instructions have been provided. This issue is a software anomaly that affects how the A610 transfers cycling settings between INSS. Notification also informing customers of a potential software crash with the A610 clinician programmer application version 2.0.4584, 2.0.4594, 2.0.4605 when interrogating the Percept PC Implantable Neurostimulator (INS). Although the A610 Clinician programmer may crash, the INS continues to provide programmed therapy. Steps for mitigations provided in the notification.

Affected products