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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 005 09 17 003
Date submitted: 11/19/2017
Manufacturer:St. Jude Medical Inc.
Device Type:Accent/ Anthem, Accent MRI/ Accent ST, Assurity/ Allure and Assurity MRI devices
Description:Pacemaker
Medical Device Identifier:Accent/ Anthem, Accent MRI/ Accent ST, Assurity/ Allure and Assurity MRI devices

………………………….

FDA update codes:

- Please Check attached file for update codes -
Reason of Field Safety Corrective Action:Availability of new pacemaker firmware (a type of software) that is intended to address the risk of unauthorized access to St. Jude pacemakers that utilize radio frequency (RF) communications (i.e., Accent™/ Anthem™, Accent MRI™/ Accent ST™, Assurity™/ Allure™ and Assurity MRI™). This firmware update provides an additional layer of security against unauthorized access to these devices that further reduces the potential for a successful cybersecurity attack.
Remedy Action:Patient Management Recommendations: Prophylactic replacement of affected devices is not recommended. While not intended to serve as a substitute for your professional judgment as to whether the firmware update is advisable for a particular patient, we, along with our Cyber Security Medical Advisory Board, recommend the following: 1. Discuss the risks and benefits of the cybersecurity vulnerabilities and associated firmware update with your patients at the next regularly scheduled visit. As part of this discussion, it is important to consider patient specific issues such as pacemaker dependence, age of device, and patient preference and provide them with the “Patient Communication”. 2. Determine if the update is appropriate given the risk of update for the patient. If deemed appropriate, install this firmware update following the instructions on the programmer (and listed attached). 3. For pacing dependent patients, consider performing the cybersecurity firmware update in a facility where temporary pacing and pacemaker generator change are readily available, due to the very small estimated risk of firmware update malfunction. Firmware Update Process: (see attached)
Athorized Representative/Importer/Distributor:Al-Jeel Medical & Trading Co. LTD
Report Source:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158781
Source Ref. Number:Z-0036-2018, Z-0029-2018, Z-0037-2018, Z-0030-2018
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: St Jude Medical Inc code information.pdf