Model Number MN10450-50A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Date 10/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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Event date is an estimate.
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Event Description
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It was reported that the patient had an infection at the l1 drg lead site.As result, surgical intervention may take place on a later date.
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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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Additional information received identified that patient underwent surgical intervention wherein, the l1 lead was explanted.
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Manufacturer Narrative
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An event of infection was reported to abbott.It was conveyed that the infection originates at the lead site(s), however, no explanted products were returned for analysis.As a result, a device history record was performed to review and confirm the sterility of the lead(s).Based on the documents reviewed, the source of the infection remains unknown.
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Search Alerts/Recalls
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