Model Number LNQ11 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/13/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.
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Event Description
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It was reported that the implantable cardiac monitor (icm) device reached recommended replacement time (rrt) earlier than expected.The device 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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Correction: due date is (b)(6) 2016.
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Manufacturer Narrative
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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.Recommended replacement time (rrt) alert was triggered on (b)(6) 2016 due to impedance.Daily battery trend data shows gradual rise of battery impedance.Premature rrt alert, without corresponding battery depletion.This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.A good faith effort will be made to obtain the applicable information relevant to the report.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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Search Alerts/Recalls
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