MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Inadequate Instructions for Non-Healthcare Professional (2956)
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Patient Problems
Diarrhea (1811); Electric Shock (2554)
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Event Date 11/27/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a patient regarding their implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.Patient said they were having issues with it effecting their bowel.During the call, they were able to connect and increased to 1.0v on program 4, but they felt a shocking in their penis which was strong.The caller then said they were getting control of their bladder, but the bowel is the issue.The patient then said their "bowel gets crazy on them, and the stool is very loose and wet, like diarrhea".The patient also said they don't remember much from the surgery as they were still under anesthesia when they were trained.During the call, they decreased stimulation to 0.8v.As a result of what was reported, the patient will monitor symptoms now that change was made and follow up with the healthcare provider (hcp) if it doesn't resolve.No further patient complications have been reported as a result of this event.
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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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Additional information was received from a consumer indicating that the shocking issue had not been resolved.No further complications were reported.
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Search Alerts/Recalls
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