Model Number LNQ11 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/01/2016 |
Event Type
malfunction
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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 by the patient that the implantable cardiac monitor (icm) had "somewhat falling out of place"sometime prior to removal six months after implant.The device has been explanted.No 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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