Model Number LNQ11 |
Device Problems
Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017); Material Protrusion/Extrusion (2979)
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Patient Problem
Pain (1994)
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Event Date 06/21/2018 |
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) patient has been in pain for four and a half months due to the device being implanted ¿in such a way that it tented through the skin¿ and that the device is ¿so close to the surface that it¿s poking out¿.The icm is expected to be explanted.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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