Model Number 3189 |
Device Problem
Material Protrusion/Extrusion (2979)
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Patient Problem
Erosion (1750)
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Event Date 02/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Device 2 of 2.Reference mfr report #1627487-2019-02601.It was reported the patient experienced erosion and both leads appeared to be protruding out of the skin.In turn, the patient underwent surgical intervention wherein both leads were explanted and replaced.
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Manufacturer Narrative
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It was inadvertently reported in the initial report that the leads were replaced, rather the leads were explanted but not replaced.
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Event Description
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Device 2 of 2.Reference mfr report #1627487-2019-02601.
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Search Alerts/Recalls
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