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الثلاثاء - ربيع الآخر 22, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-26-01-25-766
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
LivaNova’s Model 1000 SenTiva™ and Model 1000-D SenTiva Duo™ VNS Therapy™ generators
الأجهزة المتأثرة
Model 1000 SenTiva™ and Model 1000-D SenTiva Duo™ VNS Therapy™ Generators
الممثل المعتمد
Cigalah Pharmaceutical Stores
سبب المشكلة
The potential of a small percentage of implanted Model 1000 and Model 1000-D generators may stop delivering therapy due to a component issue.
الإجراء التصحيحي
LivaNova is updating the VNS Therapy Instructions for Use (IFU) to reflect the patient management recommendations relevant to this issue. LivaNova provided actions that should be taken by physicians which can be found in the attachment, refer to the attachments for more information. -------------- September 2025 Update: LivaNova has now obtained applicable marketing authorization to distribute updated versions of the Model 1000 SenTiva™ and Model 1000-D SenTiva Duo™ VNS Therapy™ generators with a design change to resolve the reed switch component issue. As a result, LivaNova will be replacing all potentially affected Model 1000 or Model 1000-D generators that remain in your inventory, free of charge. Manufacturer action: Instructions and Removal.
المرفقات
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