Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Inadequate Pain Relief (2388)
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Event Date 06/05/2018 |
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 was experiencing ineffective stimulation after fall.Reprogramming was attempted to no avail.Patient reported fall.X-rays revealed leads migrated.As a result, surgical intervention is pending to address the issue.
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Event Description
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Additional information identified that surgical intervention was undertaken wherein the patient¿s lead was revised.During the procedure the physician cut the lead with an electrosurgical device.The lead was explanted and replaced.Impedances were within normal range.
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Event Description
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Additional information received indicated the patient is reportedly receiving effective therapy utilizing the replacement lead.
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Search Alerts/Recalls
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