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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 119 02 13 000
Date submitted: 2/17/2013
Manufacturer:Medtronic Inc
Device Type:Symplicity™ Catheters
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.
Remedy Action: 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.
Athorized Representative/Importer/Distributor:Gulf Medical Co, Jeddah, (02)6512828
Report Source:NCMDR
Source Ref. Number:862296333E1AF
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic Inc (1).pdf