Advice to all departments carrying out Cardiac Rhythm Management implantation and follow-up procedures – a reminder of the importance of reporting to MHRA
A concern has been raised recently of the possibility of interaction between rate response sensor activity based on minute ventilation and the increased sensitivity features available on some pacemakers and CRT-P devices. It has been suggested this could result in over-sensing and failure to deliver pacing therapy. BHRS is concerned that issues such as this could remain under-reported and dismissed as ‘simple’ lead failure due to time since implant or damage during recent generator change procedure. This in turn could result in additional invasive procedures being performed, exposing patients to unnecessary risk. BHRS would like to encourage extra vigilance when reviewing devices where the programming features using minute ventilation sensor and enhanced sensitivity are in use.
URGENT FIELD SAFETY NOTICE
Information About Cybersecurity Update for Accent™/ Anthem™, Accent
MRI™/ Accent ST™, Assurity™/ Allure™ and Assurity MRI™ devices
We are advising you of the availability of new pacemaker firmware (a type of software) that is intended to address the risk of unauthorized access to our 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.
URGENT FIELD SAFETY NOTICE
Battery Performance Management Tool for Implantable Cardioverter Defibrillator with Risk of Premature Battery Depletion from Lithium Cluster Induced Shorts
We are writing to make you aware of an impending update to our Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™, and Unify Quadra™ devices manufactured between January 2010 and May 2015 which are subject to the October 11, 2016 Medical Device Advisory (“Impacted Devices”, see Table 1 below for affected devices).
ABBOTT / Update on ICD premature battery depletion advisory
I wanted to write to provide an update regarding the ICD premature battery depletion global medical device advisory we implemented on October 11, 2016.
As you know, our company has worked to continue to better understand the issue as new information has become available and has continued to analyze returned product to provide our customers the most accurate information available.
Resusitation to Recovery
23 March 2017
A National Framework to improve care of people with out-of-hospital cardiac arrest (OHCA in England
National Audit of Cardiac Rhythm Management Devices 2014-15
3 August 2016
This 10th annual report of the National Audit of Cardiac Rhythm Management Devices (CRM Device Audit) describes cardiac device implants in hospitals in England, Wales, Scotland and Northern Ireland for the period April 2014 to March 2015.
Joint statement from Arrhythmia Alliance (A-A) and British Heart Rhythm Society (BHRS)
10 June 2016
The recent announcement of cost savings by the NHS through a national procurement approach should be commended in principle. However, A-A & BHRS calls for clarification and reassurance that patients and local services will not suffer due to clinical experts not being able to access or provide the most appropriate device for the needs of the specific patient.
Post-cardiac Device Implantation Movement and Mobilisation Advice Survey
01 March 2016
This survey is being carried out by the Cardiology Research Team at the Peterborough and Stamford Hospitals NHS Foundation Trust in Cambridgeshire. It is intended for all members of the cardiac rhythm team and concerns the advice that UK cardiac centres give to their patients after cardiac device implantation (PPM, CRT or ICD).
Proposed changes to National Tariffs for EP and CIEDs
3 September 2015
As you may be aware, there is a “National Tariff” for EP and device procedures, which is a pricing structure for activity under Payment by Results.
Statement on Device Malfunction
12 August 2015
Following recent inaccurate media reports on supposedly faulty devices, the following statement is being issued jointly by Arrhythmia Alliance and British Heart Rhythm Society.
Allied Professional Editorial Programme Competition
15 July 2015
British Heart Rhythm Society has decided to invite new submissions from allied professionals into a competition and is offering two bursaries up to a maximum of £500 to attend Heart Rhythm Congress 2015.