Model Number 3660 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Unspecified Infection (1930)
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Event Date 10/21/2022 |
Event Type
Injury
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Manufacturer Narrative
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Date of the event is estimated.During processing of this incident, attempts were made to obtain complete patient information.
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Event Description
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It was reported the patient's ipg site opened up and an infection was present.As such, surgical intervention was undergone where the ipg was explanted to address the issue.
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Event Description
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It was reported that cultures came back negative and the patient does not have an active infection.As such, the antibiotics were prescribed as a precaution.
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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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Event Description
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It was reported the ipg site has healed.
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Search Alerts/Recalls
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