Model Number 3228 |
Device Problem
Fracture (1260)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 11/11/2016 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.
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Event Description
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It was reported that the patient experienced ineffective therapy.Troubleshooting revealed high impedances indicating a possible lead fracture.As a result, surgical intervention may be undertaken to address the issue.
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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 indicates surgical intervention was undertaken on (b)(6) 2021 wherein the entire system was explanted and replaced to address the issue.
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Search Alerts/Recalls
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