MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97810 |
Device Problem
Overheating of Device (1437)
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Patient Problems
Pain (1994); Burning Sensation (2146)
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Event Date 02/27/2024 |
Event Type
malfunction
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Manufacturer Narrative
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B3: date is approximate.Month and year are confirmed valid.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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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.The reason for call was for the last month the patient has been experiencing a burning feeling to the inner side of the stimulator.When the patient turns the device off the burning goes away but when they turn it back on the pain comes back.The patient can feel the tip of the lead down by the tailbone and it doesn't bother them.The pain is almost immediate when the device is on.Patient said they left the device on for 48 hours and the pain was really bad so they turned it off and as soon as they turned off the pain went away.Patient has not had any falls or trauma that they think would interfere with the device.Patient mentioned that they have been using back patches for their back pain.Patient stated they do have chronic back pr oblems.Patient also mentioned that it takes a while to charge the implant.The patient was redirected to their healthcare provider to further address the issue.
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Manufacturer Narrative
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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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Event Description
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Additional information was received from the patient.They reported that they met with their hcp at (b)(6) 2024, and they changed to another program from program 3 to 1.5 and program one at.5 and they have been doing good since then.
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Search Alerts/Recalls
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