Model Number LNQ11 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Discomfort (2330)
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Event Date 03/24/2020 |
Event Type
malfunction
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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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Event Description
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It was reported that the implantable cardiac monitor (icm) was forced to a visible breast location due to sub pectoral breast implants.It was further reported the icm patient experienced discomfort and was not comfortable with the appearance.The icm was explanted.No further 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 and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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