Model Number 3186 |
Device Problems
Bent (1059); High impedance (1291); Low impedance (2285)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Type
Injury
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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.(b)(4).
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Event Description
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The patient has two leads from the same lot.It was reported the patient has been receiving inadequate stimulation.An impedance check was performed and revealed high and low impedance.Reprogramming was unable to address the issue.X-rays were taken and allegedly a bend was found near the anchor site(s) of the lead(s).As a result, the patient will undergo surgical intervention.
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Event Description
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Follow-up revealed the patient's leads were explanted and replaced (with a single lead/different model).Surgical intervention resolved the patient's issue.
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Search Alerts/Recalls
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