Model Number 3788 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Wireless Communication Problem (3283)
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Patient Problems
Failure of Implant (1924); Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2021 |
Event Type
Injury
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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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It was reported that patient had their scs ipg replaced for an unknown reason.Next course of action is undetermined at this time.
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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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It was reported that patient underwent a ipg replacement because the ipg became inoperable after experiencing a fall.Stimulation therapy was restored postoperatively.
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Manufacturer Narrative
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Correction h6: coding corrected from 2993 - adverse event without identified device or use problem to 3283 - wireless communication problem.
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Search Alerts/Recalls
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