ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE TRIAL LEAD KIT, 60CM LENGTH; SCS TRIAL LEAD
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Model Number 3086 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Renal Failure (2041); Sepsis (2067); Weakness (2145)
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Event Date 08/23/2020 |
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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Related manufacturer reference number: 3006705815-2020-31119.It was reported that patient had renal failure.Reportedly, patient experienced, weakness, sepsis and was admitted in the intensive care unit.As a result, the trial leads were explanted prematurely.Follow-up information identified that the patient expired.There is no known allegation from a healthcare professional that suggests the death was related to the device.
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Manufacturer Narrative
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D7 - date of explant.
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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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