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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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Reference Number:	mdprc 058 12 16 001
Date submitted:	5/16/2017

Manufacturer:	Medtronic SA
Device Type:	Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™
Description:	Cardiac resynchronization therapy implantable defibrillator
Medical Device Identifier:	Model Name: Product Model - Amplia MRI™ CRT-D SureScan™: ( DTMB2D1, DTMB1D4, DTMB2D4 ) - Amplia MRI™ Quad CRT-D SureScan™: ( DTMB2Q1, DTMB1QQ, DTMB2QQ) - Claria MRI™ CRT-D SureScan™: ( DTMA2D1, DTMA2D4) - Claria MRI™ Quad CRT-D SureScan™: (DTMA2Q1, DTMA2QQ )
Reason of Field Safety Corrective Action:	Medtronic identified an issue that may occur with all models of Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™ devices. The issue is a loss of LV pacing that occurs following a specific device programming sequence. Whenever a patient with AdaptivCRT* enabled (shipped setting) is subsequently programmed to MVP (Managed Ventricular Pacing) mode and then re-programmed back to DDD or DDDR, AdaptivCRT is not re-enabled. When this programming sequence occurs, LV pacing is not delivered, despite parameters indicating AdaptivCRT is enabled. This will result in RV only pacing which may be undesirable for the patient. LV pacing will remain disabled until a specific programming sequence is manually completed. * This feature adjusts CRT parameter values automatically while the patient is ambulatory. If AdaptivCRT is programmed to Adaptive Bi-V and LV, the feature can switch automatically between biventricular pacing and LV-only pacing.
Remedy Action:	The purpose of this field action is to notify implanting and managing physicians associated with Claria MRI CRT-D SureScan and Amplia MR CRT-D SureScan of the issue related to the AdaptivCRT functionality and to provide patient management recommendations. (Check the appendix in the attached FSN). A software update is being developed to address this issue in Claria MRI™ and Amplia MRI™ devices. ............ NCMDR Update Action: Medtronic has now obtained the necessary approvals and is ready to begin applying a programmer software update to correct the issue in the devices. Once installed on the programmer, an in-clinic device interrogation will update the patient’s device automatically. To prevent possible recurrence of the issues, the patient must continue to be programmed only with programmers that have this update. The loss of LV pacing issue will still occur if the specific programming sequence described in the original advisory letter is performed using a programmer not updated with SW034 Software Version 8.2. Please see attached file for the directions on how to apply this update to patient devices and to verify that devices.
Athorized Representative/Importer/Distributor:	Medtronic Saudi Arabia
Report Source:	NCMDR
Source Ref. Number:	D0475A47221DA, 792B248BF4247
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Medtronic (Claria MRI).pdf

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