Model Number MN10450-50A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Rash (2033)
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Event Date 01/21/2021 |
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 reference number: 1627487-2021-00909, 1627487-2021-00910.It was reported the patient experienced an allergic response.There is a raised rash across the neck and head.A patient contact material kit was ordered for allergy testing which confirmed the patient is allergic to stainless steel and nickel.The ipg and leads both have materials that could come into contact with the patient during surgery and once implanted.Surgical intervention may be pending.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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Additional information indicates the system was explanted.
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Event Description
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Additional information indicates the port plugs were explanted and replaced with modified extension leads on 15 apr 2021 to address the issue.
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Search Alerts/Recalls
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