Model Number 1458Q/86 |
Device Problems
Failure to Capture (1081); No Pacing (3268)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/14/2022 |
Event Type
malfunction
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Event Description
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During an implant procedure, a loss of pacing was observed on the left ventricular (lv) lead.The lv lead was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.
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Event Description
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Corrected information was received that a loss of capture was observed on the left ventricular (lv) lead, not a loss of pacing.
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Manufacturer Narrative
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Corrected data: b5 and h6.
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Manufacturer Narrative
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The reported event of loss of capture was not confirmed.As received, a complete lead was returned in one piece for evaluation.Electrical testing did not reveal any indication of conductor fractures or internal shorts.The lead connector passed insertion testing into the test icd device and the is-4 connector sleeve.Dimensional analysis of the connector boot was measured within the product specifications.Visual and x-ray examinations of the lead did not reveal any anomalies.
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Search Alerts/Recalls
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