MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 3058 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/26/2024 |
Event Type
Injury
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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, gastrointestinal/pelvic floor.It was reported that they had their previous system for 5 years and it was messing up so that's why they got the new one.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 healthcare provider (hcp).Regarding the statement "the device was messing up", the hcp clarified that the device was alerting that the internal battery was dead.It was unknown if this was due to normal battery depletion.The device was replaced and the issue was 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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