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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 080 11 15 000
Date submitted: 11/17/2015
Manufacturer:Medtronic Inc
Device Type:InSync® III Cardiac Resynchronization Therapy Pacemakers (CRT-P)
Description: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.
Remedy Action: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.
Athorized Representative/Importer/Distributor:Gulf Medical Co.
Report Source:NCMDR
Source Ref. Number:5369110BC0198
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic Inc.pdf