Model Number 7841 |
Device Problems
Failure to Capture (1081); Mechanical Problem (1384); 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 01/26/2023 |
Event Type
Injury
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Event Description
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It was reported that this right ventricular (rv) lead presented a lack of capture due to it getting dislodged approximately one week after it was implanted.The dislodgment was confirmed with x-ray imaging and fluoroscopy.The device was explanted and when examined, its helix was found to have problems retracting with some tissue found on it.A new device was implanted.No additional patient effects were reported.
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Event Description
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It was reported that this right ventricular (rv) lead presented a lack of capture due to it getting dislodged approximately one week after it was implanted.The dislodgment was confirmed with x-ray imaging and fluoroscopy.The device was explanted and when examined, its helix was found to have problems retracting with some tissue found on it.A new device was implanted.The device has been returned and was analyzed.No additional 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.Testing was completed to assess lead electrical performance and inner.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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