Model Number LNQ11 |
Device Problems
Premature Discharge of Battery (1057); Device Expiration Issue (1216)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/11/2018 |
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.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) was implanted approximately ten months after the use by date.The icm 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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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 further reported that the implantable cardiac monitor (icm) reached recommended replacement time (rrt) earlier than expected, suspected to be due to the device being implanted after the use by date had been reached.
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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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The implantable cardiac monitor (icm) was explanted.
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Manufacturer Narrative
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Product event summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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