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الأربعاء - جمادى الآخرة 26, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-10-12-25-1176
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Vanta™/Sequentia™ LT Clinician Programmer Application
الأجهزة المتأثرة
Model: A71200. "Clinician Programmer Application". GTIN: 00763000520083. Software versions: 2.0.2465 and 2.0.2683. Model: 977006 " Vanta implantable neurostimulator (INS)".
الممثل المعتمد
Medtronic Saudi Arabia LLC
سبب المشكلة
If the “Start Usage” button on the Current Device Status screen of the A71200 CP App is pressed more than once, a system error message is displayed prompting the user to restart the application. This issue can occur on software versions 2.0.2465 and 2.0.2683. After restarting and interrogating, the A71200 CP App then displays a Validation Error message with two (2) options: Exit Workflow or Continue. If “Continue” is selected, the error is cleared, and the programming session can proceed. However, a software issue can occur if the Exit Workflow is selected, as the session will end without clearing the error and may result in a surgical delay for additional troubleshooting.
الإجراء التصحيحي
User mitigation: • During the initial programming of a Vanta INS, press the “Start Usage” button only once • If you encounter this Validation Error, select “Continue”, which will clear the error and allow for the programming to continue. Medtronic has developed a new version (v2.0.2684 or later) of the A71200 CP App that contains a fix for this issue. Manufacturer Action: Correction.
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