MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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Model Number 97800 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problems
Incontinence (1928); Depression (2361); Electric Shock (2554)
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Event Date 08/21/2023 |
Event Type
malfunction
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Event Description
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Information was received from a patient regarding an implantable neurostimulator for the treatment of bladder issues.It was reported that the therapy is not working and they don't see any improvement.Patient states they didn't think they would be having as many accidents as they were and they have no control.Patient stated they spoke with medtronic representative, about this issue no longer than 3 weeks ago and they walked the pt through switching to a different program and increasing the therapy.Patient states its still not helping their symptoms however.Patient services walked patient through communicating with implant and patient confirmed they are on program 2 at 0.6v.Patient increased to 0.7v and described a shocking sensation but then stated it was like a pin that was sticking in their rectum.The patient mentioned they have gotten depressed because the therapy hasn't been helping their symptoms by 50%.Patient services reviewed option to switch programs.Agent walked pt through the process and pt found a program where the stim was comfortable and in the bike seat area.The patient will maintain stimulation level and will continue to track symptoms.
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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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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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Event Description
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2023-oct-17 (b)(4): information was received from a patient regarding an implantable neurostimulator for the treatment of bladder issues.It was reported that the therapy is not working and they don't see any improvement.Patient states they didn't think they would be having as many accidents as they were and they have no control.Patient stated they spoke with medtronic representative, about this issue no longer than 3 weeks ago and they walked the pt through switching to a different program and increasing the therapy.Patient states its still not helping their symptoms however.Patient services walked patient through communicating with implant and patient confirmed they are on program 2 at 0.6v.Patient increased to 0.7v and described a shocking sensation but then stated it was like a pin that was sticking in their rectum.The patient mentioned they have gotten depressed because the therapy hasn't been helping their symptoms by 50%.Patient services reviewed option to switch programs.Agent walked pt through the process and pt found a program where the stim was comfortable and in the bike seat area.The patient will maintain stimulation level and will continue to track symptoms.2024-01-03 patltr (con): no new information for event description.
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Search Alerts/Recalls
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