Model Number 3225 |
Device Problems
Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913); Impedance Problem (2950)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 05/29/2014 |
Event Type
Injury
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Event Description
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Device 1 of 2.Refer to mfr report# 1627487-2014-20113.The patient has two scs lead.It is unk which one is related to the issue; therefore, both are being reported.It was reported during the ipg replacement procedure (refer to mfr report 1627487-2014-01393) that the physician determined fluid intrusion in the scs lead wire insulation.Diagnostics revealed invalid impedance values.The patient was able to received effective stimulation with reprogramming at time; however, the patient is no longer receiving stimulation due to auto-reduction.The patient is to consult with the physician regarding surgical intervention.
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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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Event Description
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Device 1 of 2.Reference mfr.Report# 1627487-2014-20113.Further follow up identified the patient's scs leads were explanted and replaced which resolved the issue.Reportedly, the patient has effective stimulation postoperatively.
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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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