Model Number LNQ11 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Skin Irritation (2076); Impaired Healing (2378)
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Event Date 08/29/2016 |
Event Type
Injury
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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.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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Event Description
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It was reported that the patient experienced skin irritation and the implantable cardiac monitor (icm) implant site never healed.The patient reported "picking" at the site.Visual inspection of the implant site showed the outer edge of the icm was exposed through the skin.The icm was removed.No further 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.Analysis was performed and no anomalies were found.
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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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Search Alerts/Recalls
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