Model Number 3228 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Inadequate Pain Relief (2388)
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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 experienced ineffective therapy from the scs system.In turn, the patient turned stimulation off.Multiple reprogramming sessions were attempted to no avail.As a result, surgical intervention may be undertaken to address the issue.
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Event Description
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Additional information received identified that surgical intervention was undertaken on (b)(6) 2018, wherein the lead was explanted and replaced.
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Event Description
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Additional information received identified that patient was reprogrammed post-operatively an effective therapy was established.
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Search Alerts/Recalls
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