MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problems
Display or Visual Feedback Problem (1184); Unintended Collision (1429); Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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B3: date is approximate.Year is 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 friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and fecal incontinence.It was reported that the patient had fallen and the stimulator quit working.Patient just came from doctor and they said the stimulator is not broken.The patient said she has not got any relief since this device was implanted.Patient is getting message "different internal device detected, reposition over the correct device".Caller said, this is the same external equipment from the first implant.Patient doesn't think they have used the external equipment with the new stimulator yet.Caller mentioned patient had a bad reaction during the surgery.Redirected patient to health care provider to address the message on handset.
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Search Alerts/Recalls
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