Model Number 3166 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Skin Erosion (2075)
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Event Date 06/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.Manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Manufacturer defers to the patient's physician regarding medical history.
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Event Description
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Device 4 of 4.Reference mfr.Report# 1627487-2018-07395, reference mfr.Report# 1627487-2018-07397, reference mfr.Report# 1627487-2018-07398.It was reported one of the patient¿s lead was eroding through the skin.The patient experienced itching and swelling at the site.The patient is to follow up with the physician as a next course of action.
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Event Description
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Device 4 of 4: reference mfr.Report# 1627487-2018-07395.Reference mfr.Report# 1627487-2018-07397.Reference mfr.Report# 1627487-2018-07398.Additional information received identified the patient consulted a physician.No intervention is planned at this time for the lead.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Search Alerts/Recalls
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