MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
|
Back to Search Results |
|
Model Number 97800 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Electromagnetic Compatibility Problem (2927)
|
Patient Problem
Electric Shock (2554)
|
Event Date 04/05/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and urinary/bowel dysfunction.The reason for call was for mri.During the call the caller reported that they had an ekg about a year ago and turned the therapy off for it.After the ekg, they returned home and turned the therapy back on and since their body was not used to it, it shocked the caller and they screamed.The caller described it as putting a finger in an electric socket and they were very startled.They were able to turn it down.The caller reports that they now make sure to turn it down before turning it off.The caller also reports that while they are getting at least a 50% improvement in symptoms, they are not completely gone and they are not getting the same level of relief that they had with the trial.They have tried all of the programs at various intensities.The caller reports that they cannot leave their house before certain times of day or stay gone for too long due to this.The patient was redirected to their healthcare provider (hcp).
|
|
Event Description
|
Additional information was received, from the patient.They reported, that they lower the device to setting 1 and the turned it off.By the time they restarting it, they increased the settings to 8¿9.No problem since then.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|