Model Number 106 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 04/01/2019 |
Event Type
Injury
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Event Description
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It was reported that a patient was in surgery for replacement and during the case it was decided to cancel the case.Her pre-operative generator interrogation showed battery life of 75%-100%.The lead impedance was 3236.The patient was on a very low current output of 0.125 ma because she said she could not tolerate any higher output.Per information received, the reason for the replacement was due to the tolerability issues.Per programming history, 2016 the patient was set to.25ma; however there was no further titration history.Procedure was completed and both the generator and lead were replaced.The reason for this new replacement was due to the patient having persistent pain when the generator provided stimulation.The explanted devices have not been received for analysis to date.
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Manufacturer Narrative
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If implanted, give date (mo/day/yr), corrected data; initial mdr inadvertently reported incorrect date of implant.
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Event Description
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Product analysis on the lead was completed and approved.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints.Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Product analysis for the generator was completed and approved.The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the device performed according to functional specifications.
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Event Description
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The explanted generator and lead were received for analysis.Analysis is currently underway but has not been completed to date.
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Search Alerts/Recalls
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