The device was received and analyzed.The icd was interrogated, revealing the bos battery status.Five charging cycles were recorded in the devices memory.The memory content of the icd was inspected.The available iegms revealed the presence of noise in the right ventricular channel.Otherwise no anomalies were noted.Subsequently the header of the device was inspected in detail.The inspection revealed an intermittently opened connection as root cause for the clinical observation.As a result of this event, processes have been reviewed and relevant staff has been retrained.In accordance to biotroniks post-market surveillance system this occurrence represents a very rare event.The information you provided has been entered into our quality system and will be used to evaluate the device performance throughout our organization to maintain and improve the design and performance of our devices.We appreciate the timely information about your finding and regret the inconvenience that your patient and you experienced.
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