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الخميس - ربيع الأول 26, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-24-11-24-686
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
MERLIN™ PATIENT CARE SYSTEM (PCS) 3650
الأجهزة المتأثرة
MERLIN™ PATIENT CARE SYSTEM (PCS) 3650 SOFTWARE MODEL 3330 V28.0.X – V28.1.X REV 1 GTIN 05414734509725 WHEN USED WITH AVEIRTM DR LEADLESS SYSTEM
الممثل المعتمد
ALJEEL MEDICAL COMPANY
سبب المشكلة
A programmer software anomaly that may be encountered in a very specific circumstance during finalization of the AVEIR™ DR Leadless Pacemaker (LP) System. This can occur during an upgrade from an AVEIR VR to an AVEIR DR system or during a new AVEIR DR system implant. A specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail.
الإجراء التصحيحي
Updated Merlin™ PCS 3650 programmer software (version 28.3.2 rev 1 or higher) corrects the above issue. Your Abbott Representative will upgrade programmer software. Abbott is providing the following recommendations for implanting AVEIR DR LPs prior to the programmer software upgrade: • Prior to finalization, ensure robust telemetry connection. • For pacemaker dependent patients: o Consider backup pacing support through implant finalization. o During a new AVEIR DR system implant, consider implanting and finalizing the RA LP first before the RV LP if appropriate for the patient, as this order of finalization does not allow the issue to occur. • If this issue occurs during the finalization step of an AVEIR DR system, contact Abbott Technical Services Representative. Manufacturer Action: Instructions and Correction.
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