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.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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Manufacturer Narrative
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Further information was received indicating this event was a duplicate and reported in manufacturer reference number 1627487-2020-23421.Please refer to manufacturer reference number 1627487-2020-23421 for further information.
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Event Description
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Additional information received indicates that surgical intervention took place (unknown date) wherein the lead was explanted and replaced with new lead.Reportedly, therapy was restored post operatively.
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Search Alerts/Recalls
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