Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/16/2023
Event Type
malfunction
Event Description
During implant, the left ventricular (lv) lead was unable to be removed from the catheter.Another catheter was attempted for implant but was not successful.The event was resolved by explanting and replacing the lv lead.The patient was in stable condition.
Manufacturer Narrative
The reported event of failure to remove lead from catheter was not confirmed.As received, a complete lead was returned in one piece.Visual examination of the lead did not find any anomalies.The lead was able to be fully inserted and removed from the catheter with no restriction.Electrical testing did not find any indication of conductor fractures or internal shorts.S-curve was measured to be within specification.