Model Number 0673 |
Device Problems
High impedance (1291); Mechanical Problem (1384); Material Integrity Problem (2978); High Capture Threshold (3266)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2024 |
Event Type
malfunction
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Event Description
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It was reported that this right ventricular (rv) lead was not successfully implanted due to helix issue.Additional information received from the field indicating that increase in threshold and impedance were noted during the procedure.A new lead was successfully implanted.No adverse patient effects were reported.
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Manufacturer Narrative
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The device has been received for analysis.Upon completion of the analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.
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Manufacturer Narrative
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The device has been received for analysis.Upon completion of the analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.
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Event Description
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It was reported that this right ventricular (rv) lead was not successfully implanted due to helix issue.Additional information received indicates that this lead testing showed elevated thresholds and impedance issues.Moreover, the impedance was greater than 1500 and the helix would not extend properly.A new lead was successfully implanted.No adverse patient effects were reported.
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Event Description
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It was reported that this right ventricular (rv) lead was not successfully implanted due to helix issue.Additional information received indicates that this lead testing showed elevated thresholds and impedance issues.Moreover, the impedance was greater than 1500 and the helix would not extend properly.A new lead was successfully implanted.No adverse patient effects were reported.
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Manufacturer Narrative
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The device has been received for analysis.Upon completion of the analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.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.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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