LivaNova received a report that an extra over/under valve was found to be loose inside HVR reservoir lot 2307030066 included into PTS Custom Pack code IN01680H lot 2306270086. There was no patient / user involvement.

Review of LivaNova complaints database revealed no other similar issue notified for batches concerned from the market.

Territory sales manager visited Customer's facility and provided visual evidence of the event that confirmed the following findings (#AI-029554):

- one over/under valve was correctly seated into its housing on the top lid of HVR as per the technical drawing of the device

- an additional valve was floating/movable inside the device

No physical return of the part was therefore arranged.

Through follow-up communication,LivaNova also learned that complained circuit was the first one opened by Customer and that other packs from affected batch number were rejected accordingly (#AI-031721).

Based on the manufacturing process of Inspire HVR Reservoir, the over/under valve is positioned on the dedicated housing in the top HVR lid with a press-tool. There is no possibility that reservoir is missing the valve since a leak test of the reservoir is performed at the end of the assembly line. Available video and pictures were shared with the LivaNova manufacturing department and the root cause was identified in an isolated manufacturing deviation: specifically, it is very likely that an operator poorly installed the over/under valve which dropped inside the unit in the further manipulation /handling steps of the device. At this point,a second operator reasonably did not intercept the floating material and re-processed the device by fitting a new over/under valve. Newly assembled unit successfully overcame the leak test and material passed undetected at visual checks before released (Inspire and PTS manufacturing floor). As per CP_MIR_SOP_000087, the personnel will be involved in a dedicated training meeting of customer complaint.

LivaNova maintains and documents periodic customer events monitoring process in order to evaluate actions for products improvement.

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