Model Number SC-1200 |
Device Problem
Unexpected Therapeutic Results (1631)
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Patient Problems
Pain (1994); Inadequate Pain Relief (2388); Paresthesia (4421)
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Event Date 11/03/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: approximated based on the date of the revision procedure.
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Event Description
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It was reported that the patient experienced tingling throughout her lower left leg as well as increase in her low back pain and pain in the anterior surface of the right lower leg, which is a different location from her neuropathic pain.Several reprogramming sessions were performed but did not resolve the affects and provide stimulation in the areas to relieve the preexisting pain or the new pain.The patient requested the devices be explanted.
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Manufacturer Narrative
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Block b3: approximated based on the date of the revision procedure.
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Event Description
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It was reported that the patient experienced tingling throughout her lower left leg as well as increase in her low back pain and pain in the anterior surface of the right lower leg, which is a different location from her neuropathic pain.Several reprogramming sessions were performed but did not resolve the affects and provide stimulation in the areas to relieve the preexisting pain or the new pain.The patient requested the devices be explanted.Additional information was received that the patient requested the explant because she had stopped using the stimulation.
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Event Description
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It was reported that the patient experienced tingling throughout her lower left leg as well as increase in her low back pain and pain in the anterior surface of the right lower leg, which is a different location from her neuropathic pain.Several reprogramming sessions were performed but did not resolve the affects and provide stimulation in the areas to relieve the preexisting pain or the new pain.The patient requested the devices be explanted.Additional information was recieved that the patient requested the explant because she had stopped using the stimulation.
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Manufacturer Narrative
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Approximated based on the date of the revision procedure.Additional suspect medical device component involved in the event: product family: scs-paddle leads upn: m365sc8216500.Model: sc-8216-50.Serial: (b)(6).Batch: 7043731.The returned ipg and paddle lead were analyzed, and both passed all tests performed, and exhibited normal device characteristics a labeling review was performed on the implantable pulse generator, ipg, and paddle lead instructions for use, ifu.There was no evidence that the device was used in a manner inconsistent with the labeled indications.Based on all available information, engineers were not able to confirm the root cause of he patient experiencing tingling throughout her lower left leg as well as an increase in her low back pain and pain in the anterior surface of the right lower leg, which is a different location from her neuropathic pain and requesting the devices be explanted.The production record review, database analysis, and device technical analysis revealed no product issues and the ipg and paddle lead displayed normal device characteristics.
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Search Alerts/Recalls
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