Model Number 3228 |
Device Problem
Impedance Problem (2950)
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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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The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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It was reported the patient's scs system was shutting off her stimulation therapy.A diagnostic check showed high impedance on multiple lead contacts.Reprogramming of the patient's scs system did not resolve the issue.Surgical intervention may taken at a later date to address the issue.
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Event Description
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Follow up information received identified the patient's scs lead was replaced with a new one.Reportedly, the lead was found to be fractured, confirmed via x-ray.
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Search Alerts/Recalls
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