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

Date de début :

16 mars 2021

Date d’affichage :

8 avril 2021

Type de communication :

Rappel d'instruments médicaux

Sous-catégorie :

Instruments médicaux

Classification du risque :

Type II

Source :

Santé Canada

Problème :

Instruments médicaux

Public :

Grand public, Professionnels de la santé, Hôpitaux

Numéro d’identification :

RA-75335

Dernière mise à jour:
2021-04-08

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  Raison
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Produits Touchés

Percept PC DBS implantable neurostimulator

Raison

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.

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