Model Number 3228 |
Device Problem
Disconnection (1171)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 12/08/2017 |
Event Type
Injury
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Manufacturer Narrative
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In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.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 that the patient lost effective stimulation coverage due to lead migration.X-rays confirmed that lead had pulled out of epidural space.As a result, a surgical intervention may be pending to address the issue.
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Event Description
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Additional follow up revealed that patient scs system was revised on (b)(6) 2018.Diagnostic imaging revealed that patient¿s penta lead had migrated down a vertebral body and pulled partially out of epidural space.Physician moved the lead and reposition it over t8 midline.Patient¿s therapy has been turned on.
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Event Description
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Follow-up identified effective stimulation was restored following the procedure.
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Search Alerts/Recalls
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