Device Problem
Break (1069)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 11/29/2017 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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It was reported the patient's lead was damaged (details unknown).Surgical intervention may be undertaken to address the issue.Device information is unknown.
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Event Description
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Follow up information identified surgical intervention is only planned on the ipg to take advantage of burst stimulation.There is no surgical intervention planned on the lead at this time.
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Event Description
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Follow-up information revealed the patient underwent surgical intervention wherein the lead was explanted and replaced with another model.Effective therapy was restored following the procedure.
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Search Alerts/Recalls
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