Model Number 3186 |
Device Problem
Low impedance (2285)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.Additional components potentially involved in the event include: common device name: octrode, model: 3186, udi: (b)(4), serial: (b)(6), batch: a000118781.
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Event Description
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It was reported the patient was unable to enter mri mode.Diagnostics indicated low impedances on contacts 9 and 10.Surgical intervention may be pending 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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Event Description
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Additional information was received wherein the lead was explanted and replaced to address the issue.
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Search Alerts/Recalls
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