The lead underwent product analysis and a kink in at least one of the lead coils was noted past the electrode bifurcation.
The anchor tether was also visualized to be torn into two pieces and the suture partially detached from the helix.
Suspected tool imprints were identified on the anchor tether silicone helix near the tear.
Though difficult to state conclusively based on the inspection results it is believed that the most likely root cause for the anchor tether suture detachment and the observed damaged to the anchor tether helix was manipulation of the lead not consistent with our labeling.
Other than the above mentioned observations and typical implant or explant related observations, no other anomalies were identified in the returned lead assembly.
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