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 urinary dysfunction/sacral nerve stim.The reason for call was patient(pt) called to confirm their implant model /serial.Reviewed info.Patient said they are having urges every hour, it is not doing anything for them, they feel it in their toes and have had it turned off for a few weeks to see if it is doing anything for them.Pt said they are working out more and they are losing weight, they are thinking about removing it.Patient reported the device is sticking out of their butt and it is hurting them, hurting their muscle.When asked for the date of ins site issues pt said: pretty quickly after implant, it was not healing it healed perpendicular to their butt, it sticks out it has moved a lot in the past year.Pt said 2 weeks ago, they told their hcp about it and they said they could do an antibiotic patch, something fibrous.Reviewed device therapy optimization information, stim sensation information and recommended keeping a symptom diary to track results.Redirected to their hcp, pt said they are moving.Offered and sent listings.Redirected to their hcp.
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