Model Number LNQ11 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Itching Sensation (1943); Pain (1994); Burning Sensation (2146)
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Event Date 02/22/2016 |
Event Type
Injury
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Manufacturer Narrative
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This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.The device is no longer included as part of the field action.Product event summary: the device was returned, analyzed, and no anomalies were found.Analysis of the device showed normal battery depletion.
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Event Description
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It was reported that the patient is experiencing pain, itching, and a burning sensation.There were no signs of infection or irritation.The physician believes the patient's symptoms are psychosomatic.The implantable cardiac monitor (icm) was 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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