US medical device company Medtronic publishes a Field Safety Notice about one of its heart devices
Medtronic has reported that a number of its InSync® III CRT-pacemakers have been affected by problems with the long-term performance of their batteries.
The problem has resulted in the battery being unable to supply sufficient electrical current thereby affecting the pacemaker’s performance. In some cases Medtronic report some types of erratic behaviour in the device which could cause the return of heart failure symptoms in affected patients.
Medtronic has received reports of health problems from people who have been fitted with the device which include bradycardia (a slow heart rate), complete heart block, weakness and dizziness.
30 reports of injury or illness have been received by Medtronic, including two in the UK.
The affected devices are from Medtronic’s InSync III Models 8042U range and were implanted in the UK between June 2001 and October 2010. There is no provocative testing that can predict which devices will fail, and there is no programming available that can reduce the effects of the problem.
The UK’s regulatory authority, the MHRA has issued a medical safety alert on the pacemaker after being contacted by Medtronic.
The MHRA recommend that cardiac health staff carry out a number of steps, including identifying all affected patients; arranging meetings with patients to discuss the problem; and comparing the risk presented by device failure against that associated with replacing the device. Patients should also be reminded to contact their GPs or surgeons if they experience any symptoms of heart failure, such as breathlessness or a slow heart rate.
A list of the affected models is available on the MHRA website.
The MHRA estimate that some 6,000 potentially affected devices were supplied to the UK between June 2001 and October 2010.