Model Number LNQ11 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Impaired Healing (2378)
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Event Date 10/29/2019 |
Event Type
Injury
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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 approximately six months after being implanted, the implantable cardiac monitor (icm) migrated almost completely out of the patient's chest.It was noted by the patient that the incision never healed.The device 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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