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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-30-07-25-981
التفاصيل
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اسم الجهاز الطبي
RELIANCE ePTFE (GORE) defibrillation leads
الأجهزة المتأثرة
All BSC RELIANCE defibrillation leads with ePTFE coated coil(s) listed in the attachment.
الممثل المعتمد
Boston Scientific Gulf for trading LLC
سبب المشكلة
An increased potential of the affected leads to exhibit a pattern of gradual rise in low-voltage shock impedance (LVSI) which is associated with calcification of the shocking coil(s).
الإجراء التصحيحي
There are no changes to the scheduled follow-up interval for patients with ePTFE lead models. 1- Continue routine follow-up of defibrillation systems with ePTFE leads (Appendix B of the attachment) either via in-person or remote monitoring (RM). 2- During routine follow-up of affected leads, determine the most recent approximate 28-day average LVSI that has not been influenced by the delivery of a shock . 3- If lead replacement is planned, carefully consider the risk/benefit of lead extraction versus abandonment. Based on implant time and likely coil calcification, these leads may pose an increased risk of extraction-related complications. 4- There may be circumstances such as routine defibrillator replacement that merit complex decision making. Contact BSC technical services for further assistance if necessary. Refer to the attachment for more information. Manufacture Action: Instructions.
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