ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG
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Model Number 3660 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Irritation (1941); Pain (1994); Pocket Erosion (2013)
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Event Date 06/14/2020 |
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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It was reported that patient experienced pain, irritation and erosion at the ipg pocket site.Follow-up information identified that the pocket erosion was due to patient wearing a new belt that rubbed over the incision area.As a result, surgical intervention was undertaken on (b)(6) 2020, wherein the entire system was explanted to address the issue.
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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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