B3: event date is not known.Please see b5 for approximate date range, if applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urge incontinence, urinary/bowel dysfunction.It was reported that starting over the past couple of weeks they have been having to go to the bathroom every 2 hours.On 4/8 or 4/9, they increased the stim and began experiencing soreness around their butt that is like a shocking and it is making things sore and tender and they cannot sit down or recline.Helped caller connect to implant and change programs.This resolved the shocking.The caller will monitor symptoms and adjust as necessary.When connecting to the ins the caller noted "sometimes i have a hard time finding my implant. the nerves around the patients anus are painful.They can't sit or recline without a shocking sensation.
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