A medical device alert has been issued by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom in relation to implantable pace makers manufactured by Medtronic. The model in question is P1501DR which is a dual chamber responsive pacemaker. The problem with the pacemaker is that following a software update the new battery impedance Elective Replacement Indicator (ERI) threshold may trigger an unexpected ERI in some devices.
Cardiologists and cardiac physiologists who manage patients implanted with pacemakers have been advised to schedule follow up visits with their patients to identify devices that triggered ERI shortly after the software update. Patients who have not yet received the software update should be reviewed, and then again within 90 days after the software update to identify if ERI is triggered. Cardiologists have been advised to continue follow up until the device is ready for replacement –
- Every three months if the patient is pacemaker dependant
- Every six months if the patient is not pacemaker dependant
When ERI is triggered, the device reverts to VVI back-up pacing mode (65 beats per minute) which may not be adequate treatment and may cause symptoms associated with pacemaker syndrome for some patients. The pacemakers are no longer sold in the UK and all devices applied in the UK reached their use by date by August 14th 2011.
If you have been supplied with a Medtronic pacemaker device that has caused you an injury you should contact Liam Moloney, Solicitor, Naas, today on 0454 89800 to find out more about your rights or simply log onto our website www.moloneysolicitors.ie for further information.