Model Number 3244 |
Device Problem
High impedance (1291)
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Patient Problems
Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)
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Event Date 02/17/2015 |
Event Type
Injury
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Event Description
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It was reported (b)(6) the patient was not receiving effective stimulation.Lead diagnostics showed high impedances.The patient underwent surgical intervention where the lead was replaced with a new one, which resolved the issue.
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Manufacturer Narrative
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(b)(4).Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Manufacturer Narrative
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Results: the complaint for ¿high impedance¿ was confirmed.As received, microscopic inspection of the paddle lead (3244) revealed there were wires detached from the electrodes on the paddle that are consistent with overstress condition the lead was subjected while in the patient¿s body.Continuity testing showed channels 1, 2, 5, 7, and 8 were electrically open.The detached wires could have caused a change in the systems stimulation output.This would have caused the high impedance observed in the field.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Manufacturer Narrative
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Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Search Alerts/Recalls
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