Implantable Pacemaker Pulse-generator

Medtronic is informing doctors of two specific battery issues with EnRhythm pacemakers that will be addressed by a Medtronic software update available mid-2010. If the software update referenced above is not implemented, there will be a potential risk of loss of device functionality or risk for loss of therapy at or near ERI in a small number of devices. The software will eliminate this issue, fo

One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.

One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.

One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.

One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.

One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.

One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.

An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion, intermittent or total loss of telemetry, or not output. There have been no reported patient injuries or deaths due to this issue.

An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion, intermittent or total loss of telemetry, or not output. There have been no reported patient injuries or deaths due to this issue.

An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion, intermittent or total loss of telemetry, or not output. There have been no reported patient injuries or deaths due to this issue.