Model Number 1458Q/86 |
Device Problems
Product Quality Problem (1506); Fitting Problem (2183); No Pacing (3268)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This product is registered as a combination product.
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Event Description
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During the implant procedure, the df4/is4 connector could not properly fit onto the left ventricular (lv) lead.Other df4/is4 connectors were attempted to be used but also could not properly fit onto the lv lead, so a lead malfunction was suspected.The lv lead was explanted and replaced to resolve the event.The patient was in stable condition.
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Manufacturer Narrative
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The complete lead was returned for analysis with reported events of a fitting problem during implant.Electrical tests did not find any shorts or discontinues on any of the conduction paths.The lead connector passed insertion testing into test icd device, but failed insertion test into the test is-4 connector sleeve.Dimensional analysis identified an over-sized diameter in a section of the connector boot that may have contributed to the sleeve insertion failure and reported field events.
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Event Description
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During the implant procedure, the df4/is4 connector could not properly fit onto the left ventricular (lv) lead which resulted in a loss of pacing.Other df4/is4 connectors were attempted to be used but also could not properly fit onto the lv lead, so a lead malfunction was suspected.The lv lead was explanted and replaced to resolve the event.The patient was in stable condition.
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Search Alerts/Recalls
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