Model Number MN10450-50A |
Device Problems
Fracture (1260); Impedance Problem (2950)
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Patient Problem
Pain (1994)
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Event Date 07/05/2020 |
Event Type
Injury
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Manufacturer Narrative
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¿date of event¿ is estimated.Patient weight was not obtained due to patient declining to provide it.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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Related manufacturer reference number: 1627487-2020-23687.It was reported that patient experienced pain in right groin/testacle area.Diagnostic testing revealed invalid impedance on multiple contacts of the right-side lead located at l1.Reprogramming did not resolve the issue.Surgical intervention occurred during which the lead was explanted and replaced to address the issue.It is unknown which lead is related to the issue so all suspected leads are being reported.
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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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Manufacturer Narrative
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Corrections: b5: the following should also have been entered in the initial report: "the lead was fractured." h6 - device code: "1260 - fracture" should have been entered rather than "2950 - impedance problem".
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Search Alerts/Recalls
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