ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD
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Model Number 3186 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/30/2020 |
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: 3006705815-2020-02817.It was reported that during an anchor surgery, (related manufacturer reference number 1627487-2020-22883 and 1627487-2020-22882) the physician cut the leads lead.As a result, the lead was explanted and replaced to address the issue.It is unknown which lead is related to the issue.Therefore, all the suspected leads are being reported.
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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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