Model Number 3225 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 08/18/2022 |
Event Type
Injury
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Manufacturer Narrative
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Date of the event is estimated.
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Event Description
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Related manufacturer reference number: 1627487-2022-06077.It was reported the patient was admitted to the hospital and diagnosed with an infection at the lead site.As such, the patient was given iv antibiotics and the patient's scs cervical system was explanted to address 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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Event Description
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It was reported the patient is to be implanted with a new system, as such, it was determined that the infection had resolved.
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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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