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الأربعاء - ربيع الآخر 23, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
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EN
SA-16-12-24-707
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
ACCOLADE™ Family of Pacemakers and CRT-Ps
الأجهزة المتأثرة
ACCOLADE™, PROPONENT™, ESSENTIO™, and ALTRUA™ 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST™ and VALITUDE™ cardiac resynchronization therapy pacemakers (CRT-Ps) Please refer to Table A in the attachment: Affected Product Names/Models/GTIN Numbers. .................................................................................................................. Updated Codes: All dual chamber (DR) extended life (EL) pacemakers and cardiac resynchronization therapy pacemakers with a use-by-date on or before 30 June 2025, please refer to the attachment for more details.
الممثل المعتمد
Boston Scientific Gulf for trading LLC
سبب المشكلة
An increased potential of exhibiting a high impedance condition because of unanticipated concentration of lithium salts resulting from variability of battery assembly techniques. This may result in a lack of available electrolyte between the battery anode and cathode.
الإجراء التصحيحي
1- Individual patient evaluation. Promptly identify patients within the advisory population who are at risk of harm due the non-programmable parameters in Safety Mode. 2- Replacement. Safety Mode. If a device enters Safety Mode, perform emergent replacement for patients who are at risk of harm. For other patients, non-emergent replacement is recommended. When choosing a replacement interval, do not rely on previously reported battery time remaining estimates which do not account for Safety Mode’s increased outputs nor the battery’s high impedance state. For more details refer to the attachment. Manufacturer Action: Instructions. .............................................................................................................................. Update Action: Boston Scientific has developed a software upgrade designed to prevent pacemakers in the ACCOLADE family from initiating Safety Mode in an ambulatory setting due to a high battery impedance state. Once this software is released, Boston Scientific will recommend that patients come in for in-person follow-up visits to upgrade their device’s software, rather than undergo prophylactic replacement. Please follow the recommendations found in the attachment (Table 2). Manufacturer Action: Instructions and correction.
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