Model Number LNQ11 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/03/2015 |
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.(b)(4).
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Event Description
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It was reported that while explanting the implantable cardiac monitor, it was noted that the coating on the electrode partially came off.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the device was returned, analysis was performed and no anomalies were found.The returned device had a damaged connector.
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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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