Model Number LNQ11 |
Device Problem
Signal Artifact/Noise (1036)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Date 06/13/2016 |
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 that the patient presented to the emergency department with "symptoms." it was noted that the implantable cardiac monitor (icm) exhibited noise.The device remains in use.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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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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