Model Number LNQ11 |
Device Problems
Incorrect Measurement (1383); Unable to Obtain Readings (1516); Under-Sensing (1661); Communication or Transmission Problem (2896)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/04/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the implantable cardiac monitor (icm) experienced undersensing which led to no markers, no histogram data and no night time cardiac data being shown.The icm remains in use.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the implantable cardiac monitor (icm) experienced partial telemetry.The icm was explanted and replaced.
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Search Alerts/Recalls
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