Model Number LNQ11 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/21/2015 |
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.Concomitant medical products: 3058 interstim urinary mgu ipg, implanted: (b)(6) 2011; 3037 neuro programmer.(b)(4).
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Event Description
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It was reported that the implantable cardiac monitor (icm) triggered an early recommended replacement time (rrt) alert without corresponding battery depletion.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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This device was included in that field action.Based on the information received and without the return of the product, it could not determine this device performed as described in the field action.
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Search Alerts/Recalls
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