Model Number 0672 |
Device Problems
Signal Artifact/Noise (1036); Mechanical Problem (1384); Contamination /Decontamination Problem (2895); Positioning Problem (3009); Device Contaminated at the User Facility (4064)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2022 |
Event Type
malfunction
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Event Description
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It was reported that this right ventricular (rv) lead exhibited poor measurements during the implant procedure.Noise from interaction with an abandoned lead was also observed.The lead was repositioned four times, but the measurements did not improve; the lead dislodged during the procedure when placed in the right ventricular outflow tract (rvot).After this, the helix would not fully extend.The lead was removed from the patient and tissue was noted entwined on the helix.The tissue was removed but still the helix did not fully extend and the procedure was completed with a new lead of the same model.No adverse patient effects were reported.The attempted lead was expected to be returned for analysis.
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Event Description
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It was reported that this right ventricular (rv) lead exhibited poor measurements during the implant procedure.Noise from interaction with an abandoned lead was also observed.The lead was repositioned four times, but the measurements did not improve; the lead dislodged during the procedure when placed in the right ventricular outflow tract (rvot).After this, the helix would not fully extend.The lead was removed from the patient and tissue was noted entwined on the helix.The tissue was removed but still the helix did not fully extend and the procedure was completed with a new lead of the same model.No adverse patient effects were reported.The attempted lead was returned for analysis.
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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.Testing was completed to assess lead electrical performance and inner/outer insulation integrity.Measurements throughout these tests were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.A new stylet was inserted into the lead lumen without resistance.No tissue was observed in the helix, and the laboratory technician tested the helix mechanism and found it functioned as expected.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.
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Search Alerts/Recalls
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