ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PRODIGY MRI IPG, 16CH, RECHARGEABLE; SCS IPG
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Model Number 3772 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Post Operative Wound Infection (2446); Fluid Discharge (2686); Blister (4537); Swelling/ Edema (4577)
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Event Date 08/12/2021 |
Event Type
Injury
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Event Description
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It was reported that the patient had an infection at the ipg site.As a result, the patient¿s scs system was explanted.It was noted that the patient was prescriber antibiotics through a picc line.
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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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