Model Number LNQ11 |
Device Problems
Premature Discharge of Battery (1057); False Positive Result (1227)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/29/2015 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the battery impedance trend was rising.(b)(4).
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Event Description
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It was reported that the implantable cardiac monitor (icm) had reached premature recommended replacement time (rrt).The device algorithm falsely triggered rrt.End of service (eos) was automatically tripped thirty days after the rrt trigger occurred.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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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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