It was reported, that the patient presented to the hospital for a scheduled implant procedure.During the procedure, the stylets wouldn't advance into the left ventricular (lv) lead lumen.The physician attempted several times, but was unsuccessful.The lv lead was removed and replaced.The patient was in stable condition.
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The reported event of the stylets wouldn't advance into the left ventricular (lv) lead lumen was confirmed.As received, a complete lead was returned in one piece.Visual inspection of the lead did not find any anomalies, but x-ray examination showed that the inner coil was offset at the connector region located under the serial number label consistent with procedural damage.Guidewire insertion test was performed and verified guidewire insertion restriction at the connector region.The cause of the reported event was isolated to the offset inner coil at the connector region consistent with procedural damage.No other anomalies were seen.
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