The main component of the system and other applicable components are: product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2017, product type: lead.Product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2017, product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Additional information received from the healthcare provider (hcp) indicated that the patient complained of no relief of symptoms with the device.Increasing the settings resulted in complaints of stomach pain and cramping.Despite multiple adjustments over about 6 months, the patient ultimately asked for the device to be removed.They stated that there was a lack of response for therapy, and the device seemed to be functioning.There were no further complications reported as a result of this event.
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