Model Number 1194 |
Device Problem
Migration (4003)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 01/17/2024 |
Event Type
Injury
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Event Description
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Related manufacturer reference number: 3006705815-2024-01063 and 1627487-2024-00711.It was reported that the patient's anchors have pulled lose and the lead migrated.The patient coughed very hard and the physician thinks this attributed to the anchor issue.Surgical intervention took place where the lead and anchors were explanted and replaced to address the issue.The ipg was electively replaced effective stimulation was restored.
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Manufacturer Narrative
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Date of event estimated.During processing of this incident, attempts were made to obtain complete device information.Further information was requested but not received.
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Manufacturer Narrative
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Date of event estimated.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.
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Search Alerts/Recalls
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