Model Number STQ4-SPR-B0 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 09/20/2023 |
Event Type
Injury
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Event Description
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The patient reported pain at the incision site.The patient has not used therapy since the permanent device was implanted.An explant procedure was performed on (b)(6), 2023.The patient is doing fine and no further issues have been reported.
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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 waa providing therapy when the new pain occurred, the patient experiencing heat sensation/shock, and changing the waa parameters intentionally or unintentionally, and the patient experiencing new pain in a new area that is not targeted for therapy have been ruled out as potential causes.However, migration was confirmed.The physician stated the pain had nothing to do with the implant, the site was not infected and antibiotics were not prescribed.The stimulator is used to treat pain.The cause of the reported issue is due to migration.However, the cause of the migration 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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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 waa providing therapy when the new pain occurred, the patient experiencing heat sensation/shock, and changing the waa parameters intentionally or unintentionally, and the patient experiencing new pain in a new area that is not targeted for therapy have been ruled out as potential causes.However, migration was confirmed.The physician stated the pain had nothing to do with the implant, the site was not infected and antibiotics were not prescribed.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 capa-2023-0013 correction 2.
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Event Description
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The patient reported pain at the incision site.The patient has not used therapy since the permanent device was implanted.An explant procedure was performed on (b)(6) 2023.The patient is doing fine and no further issues have been reported.
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Search Alerts/Recalls
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