Model Number FR8A-TRL-A0, FR8A-TRL-B0 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
Pain (1994)
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Event Date 02/05/2024 |
Event Type
Injury
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Manufacturer Narrative
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The unintended stimulation/new pain questionnaire was reviewed for causes of the reported issue.The clinical representative confirmed that the patient was reporting normal procedural pain from the trial procedure.The stimulator is used to treat pain.The cause of the reported issue is due to normal post procedural pain.Therefore, conclusion has been selected as no problem/fault found.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in unintended stimulation/new pain issues.Unintended stimulation/new pain issue rates remain acceptably low; thus, a capa is not required.Unintended stimulation/new pain issues rates will continue to be tracked and trended.
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Event Description
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The patient reported some pain after their trial procedure.The clinical representative stated that the patient was experiencing normal procedural pain from the trial as the issue was reported less than 24 hours after implantation.The patient is doing much better, they are no longer in pain, and will be moving forward to a permanent implant.
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Search Alerts/Recalls
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