Model Number LNQ11 |
Device Problems
Under-Sensing (1661); Device Sensing Problem (2917)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/03/2019 |
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 on the day of implant the implantable cardiac monitor (icm) experienced a sensing issue.It was further reporter that there may have been fluid in the pocket causing small r waves.The device was removed and another icm implanted.A weak signal was reported with the second device.The device was repositioned and a better signal was achieved.No 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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