Just to clarify, the transmitter issue was detected in a very...

Just to clarify, the transmitter issue was detected in a very small subset of the entire lot manufactured to date, and I'm unsure of it being made of a cheap and inferior material nor of it being of Chinese manufacturing origin - that has never been stated.

The Annual Report:
"...Implementing changes to rectify battery transmitter issue
" During the year, EBR identified an increased rate of battery depletion caused by the transmitter in a subset of WiSE devices. The issue was picked up as part of ongoing technical assessments and subsequently, EBR issued a notification to customers in line with regulations and industry best practice.
"The Company is confident that the issue will not impact the headline data or timing of the SOLVE trial. Affected devices were able to continue functioning normally and deliver biventricular pacing until the battery was depleted. The Company has actively been working toward a solution which will be completed prior to PMA submission to the FDA in the second half of 2023."


21st Oct 2022 Announcement:
"Background
"Following ongoing technical assessments, EBR has identified a potential increased rate of battery depletionaffecting a small number of WiSE® systems. Preliminary analysis confirmed the cause as an insulation breachin the system’s transmitter, which may result in the development of a leakage pathway, leading to the batterydraining at a faster rate than normal.

"The issue has been clinically confirmed in 1 patient representing a device failure rate of 0.8%, with an additional 7 devices suspected of having a similar issue which could raise the failure rate to 6.3%.
"There have been no reported complications to patient health or safety as a result of this issue to date.EBR continues to investigate the issue further, however the Company believes that this will not affect the outcomes of the pivotal SOLVE-CRT (“SOLVE”) trial and said devices will continue to function normally and deliver biventricular pacing until the battery is depleted."