Supplemental report is being filed since the results of investigation are available.Device history record (dhr) of the complaint lot was reviewed.The lot was inspected and released in compliance with all requirements.The sample was not returned for investigation; therefore, an evaluation of the complaint product for deficiency of construction could not be performed and the root cause remains unknown.Without a specific assignable rot cause, no specific corrective actions can be completed; however, we will continue to monitor this failure mode for this product.
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