Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Post Operative Wound Infection (2446)
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Event Date 06/13/2022 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.
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Event Description
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Related manufacturer number: (b)(4).It was reported the patient experienced redness, drainage and irritation to the ipg and lead site due to an infection.Patient was treated with oral antibiotics.As a result, the entire scs system was explanted.
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Manufacturer Narrative
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As a result, a device history record was performed to review and confirm the sterility of the ipg and lead(s).Based on the documents reviewed, the source of the infection remains unknown.
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Event Description
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Additional information received indicates that the patient has fully healed from the infection.
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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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Search Alerts/Recalls
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