Model Number 0672 |
Device Problems
Mechanical Problem (1384); Under-Sensing (1661); Device Dislodged or Dislocated (2923); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/14/2023 |
Event Type
Injury
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Event Description
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It was reported that this right ventricular (rv) lead exhibited undersensing measurements on the presenting electrogram (egm) of intrinsic beats, and the rv automatic capture (rvac) feature was not successful for two months.An xray was performed and showed the rv lead was dislodged from the original position.Subsequently, a revision procedure was performed.The physician attempted to extend and retract the helix, but the helix could not be retracted completely, and it was decided to explant the rv lead.There was noticeable tissue on the helix.Additionally, it was noted that the generator suture tie had also detached.This was observed after the physician opened up the pocket for the lead revision and it was concluded that the loose generator had ratcheted the lead overtime, causing it to dislodge.The original generator was reimplanted and tied down with two suture ties and two extra suture sleeves were also placed and tied down to the new lead.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.A laboratory technician tested the helix mechanism and found it was nonfunctional, confirming the clinical observation.Based upon the clinical observations and the laboratory findings, we believe that body fluid and/or tissue inside the helix housing may have contributed to the irregularity in helix function.Then testing was completed to assess lead electrical performance, inner and outer insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, and lead body found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities regarding the undersensing and dislodgment observations.
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Event Description
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It was reported that this right ventricular (rv) lead exhibited undersensing measurements on the presenting electrogram (egm) of intrinsic beats, and the rv automatic capture (rvac) feature was not successful for two months.An xray was performed and showed the rv lead was dislodged from the original position.Subsequently, a revision procedure was performed.The physician attempted to extend and retract the helix, but the helix could not be retracted completely, and it was decided to explant the rv lead.There was noticeable tissue on the helix.Additionally, it was noted that the generator suture tie had also detached.This was observed after the physician opened up the pocket for the lead revision and it was concluded that the loose generator had ratcheted the lead overtime, causing it to dislodge.The original generator was reimplanted and tied down with two suture ties and two extra suture sleeves were also placed and tied down to the new lead.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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