A complete manufacturing and material records review for the device model s5-025 and sn (b)(4) has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.No information on the device disposition is presently available (not returned to the manufacturer after the explant).Based on the available information, it is not possible to establish a definitive root cause for the reported event.However, based on the document review performed, no manufacturing deficiencies were identified.The manufacturer is following up with the site to retrieve additional information on this event.Should an further information be received, the manufacturer will update this reporting activity.
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Fields updated: b4, f6, f7, f10.The manufacturer updated section f10 with the "health effect - impact code" which is a new field introduced with the new medwatch, and not previously submitted with the intiial report.The remainder of the information previously submitted is unchanged.
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