Model Number 3228 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 10/27/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported the patient was not receiving effective stimulation and requested that the scs system be explanted.The patient is pending a surgical consult.
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Manufacturer Narrative
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Date of explant is unknown.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: 3006705815-2020-30994.Additional information was received surgical intervention was undertaken wherein the entire system was explanted at unknown date to address the issue.
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Search Alerts/Recalls
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