MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problems
Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Data Problem (3196)
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Patient Problems
Incontinence (1928); Insufficient Information (4580)
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Event Date 03/16/2024 |
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 urge incontinence, urinary/bowel dysfunction.It was reported that the therapy is not working for them.They are not getting any stimulation and have increased the use of diapers over the past 3-4 days.They tried to change the program and got a message that the handset could not find the stimulator.Reviewed to unplug the communicator.Caller was able to connect to ins and change programs.The caller was able to change to a program where they could feel the stimulation comfortably in the bike seat area.The patient will maintain stimulation level and will continue to track symptoms.Redirect to doctor if issue persists.The caller reported that they thought they changed the program previously, but when they connected, they were on a different program.The caller thought that perhaps the buzzing from a recent dental drill at a dental appt caused it to change.Reviewed that is unlikely.Suggested the patient write down the settings in a notebook.
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Event Description
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Additional information was received from the patient.They reported that the issue had been resolved.
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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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Search Alerts/Recalls
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