Model Number 6172 |
Device Problem
Low impedance (2285)
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Patient Problems
Inadequate Pain Relief (2388); Movement Disorder (4412)
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Event Date 01/12/2024 |
Event Type
Injury
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Event Description
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Related manufacturer reference number: 3006705815-2024-02138.It was reported that patient experienced a fluid intrusion at the ipg site, patient also experienced ineffective therapy and was unable to enter mri mode.Patients lead had low impedances.As a result, surgical intervention was undertaken on (b)(6) 2024 wherein ipg and lead were explanted and replaced to address the issue.
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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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Additional information indicates that lead was not explanted and replaced lead was disconnected and whipped off to address 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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Search Alerts/Recalls
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