Model Number 0672 |
Device Problems
Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
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Patient Problems
Device Overstimulation of Tissue (1991); Cardiac Perforation (2513)
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Event Date 02/22/2023 |
Event Type
Injury
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Event Description
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It was reported that this right ventricular (rv) lead high pacing thresholds, phrenic nerve stimulation, and dislodgement.Lead perforation was also suspected; however, no additional intervention was required.A new rv lead was successfully placed.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.The lead was returned intact (not severed) with the helix mechanism in a retracted position.Setscrew marks were in the correct location on the terminal pin.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.Laboratory testing is not able to provide relevant information for the type of allegations made on this case, but 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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Event Description
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It was reported that this right ventricular (rv) lead showed high pacing thresholds, phrenic nerve stimulation, and dislodgement.Lead perforation was also suspected; however, no additional intervention was required.A new rv lead was successfully placed.No additional adverse patient effects were reported.The device was returned for analysis.
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Search Alerts/Recalls
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