Model Number 97800 |
Device Problems
Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927)
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Patient Problems
Diarrhea (1811); Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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B3: event date is not known.See b5 for context 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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Event Description
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Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel disfunction and fecal incontinence.It was reported that patient was hospitalized and since then they were having very loose stools.Caller wondering if there was a specific adjustment for these symptoms.Reviewed therapy adjustment options.Caller will adjust therapy as needed.Redirect to hcp if issue persists.
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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 a healthcare professional (hcp).The hcp reported that the hospitalization was not related to the ins.Patient deceased as a result of their cancer.
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Search Alerts/Recalls
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