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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 080 11 15 000
InSync® III Cardiac Resynchronization Therapy Pacemakers (CRT-P)
multi-programmable, rate responsive, implantable AV synchronous biventricular pacing device for cardiac resynchronization.
Medical Device Identifier:
Models 8042, 8042B, 8042U
Reason of Field Safety Corrective Action:
Through 27 October 2015, Medtronic has confirmed 30 devices (0.03%) worldwide have been impacted by this issue, for which the root cause is unexpected high battery impedance.
Medtronic realizes that each patient requires unique clinical consideration. After consultation with Medtronic’s Independent Physician Quality Panel (IPQP), Medtronic offers the following recommendations for patients with an InSync III CRT-pacemaker:
• Prophylactic device replacement in non-pacemaker-dependent patients is not recommended.
• For pacemaker-dependent patients, physicians should carefully weigh the risks and benefits of device replacement to mitigate this issue on an individual patient basis. o The estimated per patient mortality risk of this issue (0.007% to 0.02%) is comparable to the estimated per patient mortality risk of complications associated with an incremental, early device replacement (0.005%).
• Continue routine patient follow up in accordance with standard practice, and advise patients to seek medical attention immediately if they experience new or unexpected symptoms.
Gulf Medical Co.
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.