Boston Scientific is writing to share information related to the tined lead component of the Axonics SNM System® Tined Lead Kit (model 1201). Boston Scientific has identified that in a small percentage of cases, users may experience difficulty advancing the tined lead through the introducer sheath during implantation, requiring device exchange during the procedure. Investigation determined that difficulty advancing the lead may be due to the amount of adhesive applied to the tine component during manufacturing, which may prevent them from fully deflecting within the sheath. Boston Scientific has since introduced controls to prevent this issue occurring in the future. This issue only affects sheath compatibility; the performance of implanted tined lead devices is not affected.
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