EBR Systems (ASX:EBR) completed its internal review into an incident where a patient implanted with the Wireless Stimulation Endocardially (WiSE) system died during post-implant echocardiograms, concluding that this was an "isolated event" related to a disclosed risk that can be mitigated when following recommended imaging procedures per the device labelling and training, according to a Friday Australian bourse filing.
Two patients at one site implanted with the WiSE system separately developed ventricular fibrillation during next-day, post-implant, transthoracic echocardiograms, the company said. One patient went into cardiac arrest, could not be resuscitated, and died.
There have been no previous reports of patient death due to this complication, it noted. To date, the only occurrences in the commercial experience have been the two that occurred at one site on the same day.
The company's shares climbed nearly 4% in recent trading on Friday.