Model Number LNQ11 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Chest Pain (1776); Swelling (2091)
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Event Date 06/18/2015 |
Event Type
Injury
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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 patient complained of chest pain and swelling at the insertion site of the implantable cardiac monitor (icm).It was suspected that the icm had exhibited within-pocket migration downward relative to the insertion site.At the patient¿s request, the icm was removed and not replaced.The patient is a participant in the product surveillance registry.No further patient complications have been reported as a result of this event.
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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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