Model Number 3058 |
Device Problems
Premature Discharge of Battery (1057); Failure to Interrogate (1332); Energy Output Problem (1431); Battery Problem (2885); Communication or Transmission Problem (2896); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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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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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that patient said it is not working.When patient goes to turn the sti mulation up or down it won't stop.The indicator on the screen just keeps going back and forth it won't find the device.Patient said this has been going on for a while at least a month or two.They thought it started in 2023.Walked caller through connecting to their stimulator and got a message end of service.Redirected patient to their doctor.Patient said their doctor isn't there he left.Sent patient doctor listings.
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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.It was reported that the device malfunctioned.This was caused by normal battery depletion/battery went dead.Device was replaced on (b)(6) 2024.Issue has resolved.
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Event Description
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Additional information was received from a healthcare professional (hcp).The hcp reported that the surgery center always discards devices that are no longer operational and both the ins and the lead were determined to be no longer operational.
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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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