Model Number 1458Q/86 |
Device Problems
Failure to Capture (1081); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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This product is registered as a combination product.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Related manufacturer report number: 2017865-2021-01079.It was reported that the patient presented for a lead revision.Prior to procedure, it was noted that the left ventricular lead exhibited loss of capture.At original implant, the lead had demonstrated capture with high capture threshold.Additionally, it was found that the atrial lead was exhibiting loss of capture as well.The leads were explanted and replaced.The patient was in stable condition.
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Manufacturer Narrative
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Additional information: b5, d10, h3, h6.
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Event Description
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New information received noted that the atrial and left ventricular leads were dislodged.
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Manufacturer Narrative
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Analysis found that a complete lead was returned in one piece measuring 86.0 cm.The damage found was sustained during the surgical procedure.The lead was otherwise normal.
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Search Alerts/Recalls
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