Model Number 3660 |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 05/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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It was reported that the patient lost therapy and received a message stating that the ipg needs to be replaced following a magnetic resonance imaging (mri) scan.The ipg was not put into mri mode.As a result, surgical intervention took place on (b)(6) 2020 wherein the ipg was explanted and replaced with a new ipg resolving the issue.Therapy has been resumed post operatively.
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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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Search Alerts/Recalls
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