General Investor Information EBR Systems, page-269

Hey @longreach, reply function not working.

Some time ago I also asked about the need for further testing. The abrasion test was mentioned too. When I researched power depletion issues for pacemakers and defibrillators, there were a myriad of causes including a thing called lead impedance. Lead impedance is a bit like a nerve that can’t send a signal to a muscle. (I suffer from this damn pinched nerve!) So if a lead moves, fractures or rubs up against tissue (abrasion) it can result in energy loss between the transmitter and the battery. Also, defective material in the lead can cause it. In general, these issues are quite common in the cardiac pacing world. I mentioned other companies have issued advisories around this, as it’s an FDA requirement to keep patients informed. Usually it means a device needs to be monitored more closely. I’m glad EBR told the market there was an issue in the first place although I wondered if we really needed the trading halt at the time. Seems everything is back on track now, and EBR’s caution will hopefully pay dividends in terms of FDA approval.