Model Number 3186 |
Device Problem
Fracture (1260)
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Patient Problems
Failure of Implant (1924); Inadequate Pain Relief (2388)
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Event Date 06/16/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient's one of the leads had fractured.As such, surgical intervention took place on (b)(6) 2022 where in the lead was explanted and replaced with a new lead addressing the issue.
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Manufacturer Narrative
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Date of event is estimated.Note: it is unknown which lead was fractured.Additional components potentially involved in the event include: common device name: octrode lead, model: 3186, udi: 05415067017246, serial: 19237750, batch: a000117585.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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Additional information received indicates that effective therapy was restored post op.
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Search Alerts/Recalls
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