No complaint was received with the return of the device.Failure event observed during analysis.Final analysis found that a complete lead was returned in two pieces: the connector portion measured 22.0 cm while the distal portion measured 64.0 cm.Dissection beneath the lead insulation at the s-curve region found internal insulation abrasion breaching between ring electrode cable and inner coil lumens at 4.0 -5.0 cm from distal tip.The etfe cable coating was found to be intact in this location.Abbott is continuing to monitor this issue.
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