Model Number 3186 |
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 Type
Injury
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Manufacturer Narrative
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The results, method, and conclusion codes along with the investigation results will be provided in final report.During processing of this incident, attempts were made to obtain complete event and device information.
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Event Description
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Related manufacturer reference number: 1627487-2019-13036.It was reported the patients leads eroded through the skin.Surgical intervention was undertaken on an unknown date during which the system was explanted.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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Related manufacturer reference number: 1627487-2019-13036.
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Event Description
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Related manufacturer reference number: 1627487-2019-13036.It was reported during follow up the explant surgery took place on (b)(6) 2016.
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Search Alerts/Recalls
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