Analysis of the implantable lead found no anomaly.Analysis of the epidural needle found the spoon of the needle had a sharp edge on the undercut side.Concomitant product(s): product id: neu_epiduralneedl,e lot# serial# unknown, product type: accessory.Product id: n eu_epiduralneedle, lot# serial# unknown, product type: accessory.Product id: neu_epiduralneedle, lot# serial# unknown.Other relevant device(s) are: product id: neu_epiduralneedle, serial/lot #: unknown.Product id: neu_epiduralneedle, serial/lot #: unknown.This report is a correction.Regulatory report 3007566237-2018-00087 captured the initial report.No further regulatory reports will be submitted under report number 3007566237-2018-00087.If additional information is received it will be captured in this regulatory report.If information is provided in the future, a supplemental report will be issued.
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