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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-20-08-24-567
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Vanta™ Implantable Neurostimulator (INS)
الأجهزة المتأثرة
Model: 977006
الممثل المعتمد
Medtronic Saudi Arabia LLC
سبب المشكلة
It has been received reports by Medtronic from Health Care Professionals (HCP) and patients indicating that the Model 977006 Vanta™ INS has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.
الإجراء التصحيحي
• Ensure that the Device Eligibility screen in the Model A71300 Clinician Programmer application is used during the trialing evaluation to review compatible INSs that will allow the same parameters used during the trial evaluation. • Ensure that the battery longevity tools in the Model A71200 Clinician Programmer application are used during each patient visit, to keep track of the estimated longevity of the Vanta INS. • Ensure that the patient understands the impact of therapy changes on the battery life of the Vanta INS. Please refer and follow "Recommended Mitigation" in the attachment.
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