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 12/19/2015 |
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.Recommended replacement time (rrt) was triggered on (b)(6) 2015 due to impedance.Daily battery trend data shows gradual rise battery impedance.Early rrt alert, without corresponding battery depletion.(b)(4).
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Event Description
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It was reported that the implantable cardiac monitor (icm) device displayed a premature/false recommended replacement time (rrt).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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This device was reported as included in the field action noted and returned product investigation found the device performed as described in the field action.Product event summary: the device was returned and analyzed.Analysis was performed and no anomalies were found with functional testing.Performance data collected during preliminary analysis was reviewed.It was found that prior to explant, recommended replacement time (rrt) had occurred due to the battery impedance trend rising.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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Event Description
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It was further reported that the device was explanted.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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