Model Number 3186 |
Device Problems
High impedance (1291); Kinked (1339)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Type
Injury
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Event Description
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It was reported the patient (b)(6) lost stimulation.Lead diagnostic testing revealed high impedance measurements and x-rays identified a kink in the lead.In turn, the patient underwent surgical intervention to explant and replace the lead.The date when the patient lost stimulation is unknown.Concomitant products: the implant dates for the following devices are unknown: model: 3386, scs extension.Model: 3788, scs ipg.Model: 1192, scs anchor.
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Event Description
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Follow-up revealed the patient has regained therapy.(continued) the implant date is unknown for the following device: model: 1192, scs anchor.
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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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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: complaint could not be confirmed for no stimulation.Only a partial part of the octrode was returned and it passed continuity test.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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