MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problems
Electromagnetic Interference (1194); Energy Output Problem (1431)
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Patient Problems
Abdominal Pain (1685); Incontinence (1928); Device Overstimulation of Tissue (1991); Pain (1994); Vomiting (2144); Obstruction/Occlusion (2422); Lethargy (2560); Abdominal Distention (2601); Insufficient Information (4580)
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Event Date 05/24/2023 |
Event Type
malfunction
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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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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor therapy and fecal incontinence.It was reported that they were forced to go through a security detector gate/scanner and since then they are in severe pain like the stimulation is too high, they normally have a flat stomach and it looks 9 months pregnant, they are vomiting profusely, cannot keep down solids, and cannot pass gas and they think they need their device replaced.Caller stated "i can't take the pain no more and i want to rip it out".Agent reviewed guidelines with caller and reviewed to seek emergency care if needed.The caller reported that the er does not know about this device.Agent reviewed replacement equipment would be expedited and that they will need to see the hcp for access to all programs, but they should have access to 1-2 and be able to turn off the therapy. pt called back and repeated the same information.Pt stated they have to watch what they eat and can't eat anything too hard.Pt stated they've been drinking ensures and have constant bloating and pain in the stomach.Pt stated it feels like a bowel obstruction and they feel very lethargic.Pt wanted to know if we could send a letter directly to them that goes over security guidelines.Pt services reviewed therapy guide has this information in it and reviewed the page number.Pt services redirected pt to doctor for any additional letter that needs to be written on the pt's behalf.
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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 the patient.They reported that they had uncontrollable bowel.
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Search Alerts/Recalls
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