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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 119 02 13 000
Medical Device Identifier:
Model RDN006, All lots
Reason of Field Safety Corrective Action:
All lots of Symplicity Model RDN006 manufactured prior to November 30, 2012, are potentially affected. Medtronic has observed a connection issue complaint rate of approximately 5% of devices provided since enrollment of the Symplicity ™ HTN3 trial began. These connection issues cause unstable temperature readings or lack of signal to the generator. In events where a connection failure leads to unstable temperature reading, the generator’s safety algorithm is triggered and energy delivery is terminated, or if there is a lack of signal to the generator, it will not initiate treatment, thus in either situation protecting the patient from unsafe treatment.
Per the IFU, connect the catheter into the generator prior to inserting into the patient. If you observe any of the conditions above, follow the steps below: 1. Assure the catheter connector plug is fully seated into the generator by unplugging and re‐plugging the catheter. If this resolves the issue, continue with treatment. 2. Gently wiggle the connector plug. If this resolves the issue, continue with treatment. 3. If the issue remains, replace the catheter.
Gulf Medical Co, Jeddah, (02)6512828
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Medtronic Inc (1).pdf
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.