The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: analysis confirmed the customer comment of a loose atrial connector, it was broken and that the device needed the updated battery shorting bar design.Analysis further noted that the main seal was pinched and damaged and that the lower case display wires were pinched but not compromised.All found defective parts were replaced and all other identified issues were resolved.(b)(4).
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