The patient reported a loss of therapy, cramps, and spasms.Multiple reprogramming attempts were made.The patient stopped taking prescribed neuropathy medication.There are no plans for and explant/revision procedure at this time.However, the physician will proceed with complementary therapies and discuss re-starting neuropathy medication that patient stopped taking.
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The perm - loss of therapy/no therapy questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location, not achieving paresthesia on the table, migration, and no attempts to reprogram the waa have been ruled out as potential causes.However, the physician believes pain relief changed because patient stopped taking their neuropathy medication, had several other surgeries on affected areas and changed their activity level.There is no deficiency reported with the stimulator.The stimulator is used to treat pain.The cause of the reported issue is due to the patient being a poor candidate due to health, weight, age, or mental capacity (user error - patient).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in perm - loss of therapy/no therapy issues.Perm - loss of therapy/no therapy issue rates remain acceptably low; thus, capa is not required. perm - loss of therapy/no therapy issue rates will continue to be tracked and trended.
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