Model Number 3186 |
Device Problems
Fracture (1260); High impedance (1291)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 07/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).Date of event is estimated.Further information was requested but not received.Unique device identifier (udi #): the udi is unknown because the lot number was not provided.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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It was reported that the patient lost therapy due to high impedances.Reportedly, the lead is fractured.As such, surgical intervention may take place at a later date to address the issue.
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Event Description
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Additional information received indicated no complications were note during the lead replacement procedure and the patient is experiencing effective therapy.
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Event Description
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Additional information received indicates that surgical intervention took place on (b)(6) 2020 wherein the lead was explanted and replaced with a new lead addressing the issue.
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Manufacturer Narrative
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D6b - date of explant corrected.
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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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Search Alerts/Recalls
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