Model Number 6662 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 09/23/2022 |
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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It was reported the patient experienced an allergic reaction to the nickel in the generator set screw alloy.As a result, surgical intervention may be pending to address the issue.
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Manufacturer Narrative
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A patient had their system explanted due to nickel allergy was reported to abbott.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.
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Event Description
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Additional information was received indicated the patient underwent surgical intervention wherein the system was explanted to address the issue.
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Manufacturer Narrative
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During processing of this complaint, attempts were made to obtain patient weight.
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Search Alerts/Recalls
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