Model Number 1000 |
Device Problem
Migration (4003)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/23/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4) utilized; appropriate term ¿migration¿ is not available.(note that although migration is an available medical device problem code, in this report¿s context, the migration does not reflect a problem with the functionality or delivery of therapy of the device.Therefore, a device problem code does not adequately capture the patient¿s adverse event.).
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Event Description
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It is reported that patient had an increase in movement of their generator.The physician had noted that it may require securing the attachment/anchoring the site.The top of the generator is properly secured down however the bottom of the generator is not.This patient has been referred for surgery.No known relevant surgical intervention has occurred to date.No additional or relevant information has been received to date.
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Event Description
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It was reported that the patient was referred surgery.This surgery is noted to be for patient comfort only.No other relevant information has been received to date.No known relevant surgical intervention has occurred to date.
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Event Description
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It was reported that the patient had underwent a revision surgery of their generator pocket.No device were explanted.The physician states that the reason for the revision surgery was due to patient influence.
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Search Alerts/Recalls
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