Model Number 3660 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Swelling (2091); Post Operative Wound Infection (2446); Implant Pain (4561); Swelling/ Edema (4577)
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Event Date 09/08/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.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 the patient experienced pain, redness, and swelling at the ipg site.Infection was ruled out.The patient was prescribed antibiotics.Surgical intervention may take place at a later date to address the issue.
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Event Description
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Additional information received stated that the patient underwent surgical intervention wherein the entire system was explanted.
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Manufacturer Narrative
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A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.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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Event Description
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Additional information received stated that the patient's infection and redness had resolved.The patient is doing well.
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Search Alerts/Recalls
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