MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problem
Electromagnetic Interference (1194)
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Patient Problems
Incontinence (1928); Ambulation Difficulties (2544)
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Event Date 03/25/2024 |
Event Type
malfunction
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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.It was reported that while on vacation they had issues with urinating all over and they were feeling like they were losing their balance again.Caller asked whether the airport x-ray scanner could have done something to their system.Although it would not be anticipated to have any issues there is always a possibility but since the ins was on then likely no issue was caused by the scanner.The patient was directed to their healthcare provider.
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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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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.The patient called back and reported the same therapy issues.Patient said that therapy worked at first, however, now they keep peeing their pants.Patient said they have had a lot of medication changes, but noticed the return of symptoms before the changes.When asked, patient stated they made an adjustment about a month ago.General programming guidance and the general purpose of the external devices were reviewed.Patient said they haven't kept external devices charged up so will recharge them and then make a slight increase in the setting.Patient advised to monitor and track adjustments and symptoms.
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