Model Number 103 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 03/29/2017 |
Event Type
Injury
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Event Description
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It was reported that the patient's generator had migrated, and the patient was referred for surgery.It was unknown if trauma or manipulation had occurred that could have caused or contributed to the migration.The patient later reported that the patient was experiencing pain with the migration and was going to have surgery.No surgical intervention has occurred to date.
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Event Description
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Clarification was received that the pain and migration was not related to the previous trauma.The physician believed the cause of the pain and migration was musculoskeletal.The surgery was planned for patient comfort only.No surgical intervention has occurred to date.
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Manufacturer Narrative
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Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
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Event Description
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The patient had generator replacement surgery.No analysis is necessary as the functionality of the device was not related to the reported events.
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Event Description
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As supplemental/adjunctive information, analysis was completed on the generator, and there were no performance or any other type of adverse conditions found with the pulse generator.
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Search Alerts/Recalls
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