Model Number MN10450-50A |
Device Problem
Disconnection (1171)
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Patient Problems
Pain (1994); Inadequate Pain Relief (2388)
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Event Date 04/21/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.During processing of this complaint, attempts were made to obtain patient weight, but it could not be obtained.
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Event Description
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Related manufacturer reference numbers: 1627487-2020-04539; 1627487-2020-04541.It was reported that the patient lost stimulation and experienced pain.X-ray imaging confirmed that the leads pulled out of the ipg header and a lead may be rubbing against a nerve.A steroid injection was administered, but the issue was not resolved.As a result, surgery may occur 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 reporting was received that surgery occurred in which the leads were explanted and replaced, which resolved the issue.
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Search Alerts/Recalls
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