Model Number 3688 |
Device Problem
Disconnection (1171)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 07/24/2020 |
Event Type
Injury
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Manufacturer Narrative
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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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Related manufacturer report number 1627487-2020-23603.It was reported that the patient's lead had disconnected from the ipg, causing the patient to be unable to place the ipg in mri mode.In turn, surgical intervention was undertaken on an unknown date wherein the ipg was explanted and replaced, resolving the issue.
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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 revealed that the ipg was inoperable prior to replacement.
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Manufacturer Narrative
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B5 - corrected event details to reflect reason for ipg replacement.
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Event Description
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Clarification received that the lead disconnection was the main issue, ipg was not mri compatible.Physician replaced ipg so patient is able to get mris.
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Search Alerts/Recalls
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