Medtronic has informed the European Heart Rhythm Association (EHRA) Board that it has determined that a potential separation of bonded interconnect wires from the electronic circuit may affect a small subset of Kappa® and Sigma® series pacemakers. The company has received reports of separated interconnect wires (that form electrical connections between the electronic circuitry and other pacemaker components), which can lead to loss of rate response, premature battery depletion, loss of telemetry, or no output.
This subset accounts for approximately 2% of all Kappa and Sigma pacemakers implanted worldwide and relates to devices that have been implanted for five years or longer.
Please be aware that there is a website where you may look up specific serial numbers online to determine if they are affected: http://www.kappasigmasnlist.medtronic.com/.
Based on the advice of an independent physician quality panel, Medtronic has provided physicians a series of recommendation on how to manage the affected patient population. Based on data available at present time, EHRA Board agrees with the opinion of the Independent Physician Quality Panel of Medtronic.
For the serial numbers affected, the recommendations are as follows:
- Physicians should advise their patients to seek medical attention immediately if they experience symptoms (e.g., fainting or lightheadedness).
- Physicians should consider device replacement for patients who are both pacemaker dependent and who have been implanted with a device in the affected subsets.
- Physicians should continue routine follow up in accordance with standard practice or at least every six months for those patients who are not pacemaker dependent.
EHRA Board will carefully monitor information and they become available and will issue updates of this statements as they become appropriate.