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 with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that they have been going to the bathroom a lot in the last month and wetting themself, it wasn't working right so they changed the batteries but in the process they hit the plus button a couple of times and decreased it back down they could not get it to work so they went to use it last night and saw a por message.Reviewed the meaning of por and redirected to their healthcare provider to further address the issue.Pt said they have moved, offered and sent listings.
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