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 02/19/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.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 elective replacement indicator (eri) was falsely triggered for the implantable cardiac monitor (icm) without the corresponding battery depletion.In addition, premature battery depletion was reported.The icm currently 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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