Model Number MN10450-50A |
Device Problem
High impedance (1291)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2020 |
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 during diagnostics that the patient's l4 drg lead had multiple contacts with high impedance.In turn, surgical intervention may take place at a later date 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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Related manufacturer reference number: 1627487-2021-16645, 1627487-2021-16646.Additional information received indicated that during a pre-op appointment the patient's l5 and s1 drg leads also had contacts with high impedance.In turn, surgical intervention was undertaken wherein all the existing leads were explanted and replaced 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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