Model Number FR8A-SPR-B0, FR8A-RCV-A0 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Shock from Patient Lead(s) (3162)
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Event Date 11/22/2022 |
Event Type
Injury
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Event Description
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The patient reported a very strong tingling feeling in their feet during an mri procedure.The patient is experiencing relief and the device is working.
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Manufacturer Narrative
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The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the questionnaire was completed with limited information.A potential cause of the reported issue is mri induced stimulation due to not meeting mri requirements.However, the mri was performed per the instructions for use.The waa was off and was not in the room during the mri.However, the patient has screws and pins in their lumbar which could contribute to the cause of the tingling sensation.The stimulator is used to treat pain.The cause of the reported issue is unknown.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, capa is not required. unintended stimulation/new pain issue rates will continue to be tracked and trended.
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Event Description
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The patient reported a very strong tingling feeling in their feet during an mri procedure.The patient is experiencing relief and the device is working.
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Manufacturer Narrative
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The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the questionnaire was completed with limited information.A potential cause of the reported issue is mri induced stimulation due to not meeting mri requirements.However, the mri was performed per the instructions for use.The waa was off and was not in the room during the mri.However, the patient has screws and pins in their lumbar which could contribute to the cause of the tingling sensation.The stimulator is used to treat pain.The cause of the reported issue is unknown.The investigation findings do not lead to a clear conclusion about the cause of the reported issue.Therefore, conclusion has been selected as unable to determine root cause.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, capa is not required. unintended stimulation/new pain issue rates will continue to be tracked and trended.Updated per fda (b)(4) correction 2.
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Search Alerts/Recalls
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