MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problems
Diarrhea (1811); Incontinence (1928); Dysuria (2684); Insufficient Information (4580)
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Event Date 12/01/2023 |
Event Type
malfunction
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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 fecal incontinence and urina ry/bowel disfunction.It was reported that they took a trip in december and noticed a loss of therapeutic effect.Patient was not feeling stimulation.Patient reported they were experiencing the same diarrhea symptoms and holding fluids in their bladder for a long time as it was before they had the device implanted.Prior to calling, patient tried to use the handset and communicator to check if the device was working but was unable to connect.Reviewed how to connect with patient programmer.Patient was able to connect and increase stimulation.Patient will maintain stimulation level and will continue to track symptoms.Redirect to doctor if issue persists.
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Manufacturer Narrative
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B3: date is approximate.Month and year are confirmed valid.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the patient.The patient stated they had an accident where they went #2 in their pants after trying to use the bathroom in 2 separate stores and they "still" had an accident.The patient stated it was getting worse and worse.The patient stated they were trying to connect to their settings previously, but they weren't able to connect.They stated the last time they called as soon as went into the other room after talking to agent "it stopped working" again.Agent walked the patient through connecting to their settings.The patient opted to switch to a new program and increased the stimulation to a comfortable level where they felt it in the bike-seat.The patient got 'device not responding' a few times and insisted they didn't move the communicator however they were able to simply reposition the communicator and connect again.The external devices seemed to be functioning as intended.Agent asked the patient to read their communicator sn but the patient could not find it.Patient stated they had a phone visit with their health care provider (hcp) next week.The patient was going to monitor their symptoms now that a change had been made and follow up with the doctor at their follow up appointment.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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