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MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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| Model Number 97800 |
| Device Problems
Intermittent Continuity (1121); Failure to Deliver Energy (1211); Failure to Interrogate (1332); Pocket Stimulation (1463); Communication or Transmission Problem (2896)
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| Patient Problems
Incontinence (1928); Undesired Nerve Stimulation (1980); Urinary Retention (2119); Urinary Frequency (2275); Depression (2361); Urinary Incontinence (4572); Insufficient Information (4580)
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| Event Date 01/20/2023 |
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Event Type
Injury
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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 urinary/bowel dysfunction and urge incontinence.It was reported that since implant they haven't made any progress with symptom control, said symptoms have been worse, more leakage and going 20 times per day.Patient asked for direction on connecting to make an adjustment as having difficulty connecting since sunday (b)(6) 2023 patient services reviewed navigation basics and after several attempts, patient connected to ins.Patient services reviewed therapy information including expectations and explained that time to therapeutic benefit varies.Patient services reviewed general programming guidance.Patient increased the setting during the call and confirmed stimulation in bicycle seat area and comfortable.Patient will maintain stimulation level and will continue to track symptoms.On (b)(6) 2023 additional information was received.The patient reported since they got their interstim device their symptoms are worse than they were prior to getting it (going to the bathroom 30 times a day wearing 4 diapers a day).Patient said now they have leakage, they never used to have any leakage, they can't go anywhere because they have to change 4 times a day and the leaking shows, they are urinating much more than they used to, it has been a nightmare.Patient said they have called in the past and increased their setting and that worked for only half a day.Patient said after implant the doctor did not give them anything, they said here's the device and when they call the doctors office they are told to call manufacturer, they were not taught how to use the control equipment.Worked with patient to use their control equipment and after resolving some confusion and no communicator found (and turning the communicator on).Patient was successful to sych with their ins.Initially patient increased on their current setting and patient said they noticed the feeling of stim a little bit around where the ins was located in their upper left buttock.Reviewed the option to change programs and patient wanted to and was successful to activate a new program.Patient increased stimulation and stated they did not feel any sensation on the new program.Reviewed interstim therapy optimization information, stimulation sensation information, control equipment general use and function and recommended keeping a symptom diary to track results.Offered and sent email with quick guide, symptom diary and interstim information.Redirected to their doctor.Patient will maintain stimulation level and will continue to track symptoms.
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Event Description
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Additional information was received from the patient.They reported that the ins ruined their life and said they still don't understand how it works.Patient said every day since they got the implant, they continue to have more therapy issues and can't connect to their ins.Patient stated contradictory information that they've never been able to connect to their ins but referenced this case as well, saying that those are the only times they were able to connect.Patient said now they're urinating 30 times a day rather than 20 times a day.Patient also said they are not emptying their bladder so sometimes they catheterize 4-6 times a day and they're still holding urine so their urine gets infected.Patient said they had an issue with infected urine before the ins and still have it.Patient said every time they see the hcp, the hcp seems surprised that their urine is infected.Patient said when they see the hcp they determine the urine is infected and then give them medication that lasts a week and said now they can't give them the medication anymore.Patient said even with the medication, the ins doesn't work.Patient also mentions that when they've tried to connect on their own, it takes an hour every day and then they weren't able to connect to their ins.Patient said they continue to see 'device not found' and if they get past that screen they continue to see 'device not responding' (npa239580n).On the call, patient did not have communicator powered on and that determined 'device not found'.Reviewed with patient where they should place the communicator in relation to their ins.Patient said they could feel a bump but they don't know exactly where the ins is, they just assume it's where the bump is.Patient said they've spoken to one of the reps on the phone (names or dates, unk) and they told patient "it's something you play around with" and patient expressed dissatisfaction with how long it takes them to try and connect.Please note, ps did their best to answer patient's questions and guide patient with information and patient was fairly escalated and did disconnect the call rather abruptly.Patient said they are seeing a new hcp next wednesday.
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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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Additional information was received from the patient.The pt called the spinal cord stimulator (scs) queue escalated and said their interstim implant does not work.Pt said the only time when the device was working was when they called medtronic and pats because agents temporarily helped them but the interstim device would stop working after the call.Pt said they had tried to make it work for a few days without success.Pt said the issue started after implant date in january.Pt said they were sent physician listings and "half the hcps" were foreign (which the pt did not want) and the other half did not know anything about medtronic devices.Scs agent offered the pt a call back because pt was escalated and pt reported staging record information.Pt disconnected the call after providing callback number.Scs agent emailed ph queue to fulfill callback request.An outgoing call was made to the patient but there was no answer so a message was left.
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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 stated the cause of the stimulation around where the ins was located was unknown.They wrote "according to you they have to test the stimulation several times every day.Test about 40,000 times.One of your staff said i have to test".When asked what steps were taken to resolve the issue, they reported no one has assisted.They don't look forward to every day until the vibration kicks at least an hour per day.No one is there to help.It is unknown if the issue was resolved.The cause of not feeling the stimulation sensation when changing to a new program was unknown.This has not been resolved but no further action has been taken.They wrote "i'm actually urine 30 times a day (was 20).I was now i am leaking every day all day.I change 20 diaper [illegible] 5x day.Getting worse".They later repeated that before the january 20th procedure, they were urinating 20 times per day, having to cath, and changing their diapers and underwear a couple times per day.After the procedure, they were urinating 30 times per day, leaking almost 24/7, changing their diaper/underwear/pants 5-6 times per day.They stated that the only time it works, that is working for a few hours only, was when they speak to a tech person who walks them through the procedure.They have contacted a tech person maybe 5 times and eventually they will successfully get the monitor set.The tech person said they may have to take time to adjust the monitor and device, which takes an hour per day and they don't know if the adjustment is correct.They are looking for a new urologist because their previous urologist would only remark that they have an infection in the bladder and have been saying only that for 9 months.Their routine is cathing about 6 times per day, spending collectively an hour a day to re-adjust the read between the device and the monitor, and they don't know if it works.Ninety percent of the time the adjustment doesn't work.Their life is very limited.They have to carry a coat to cover up their crotch so people don't see the urine stain on their pants.They wrote" since i leak, i can't even tell when it actually happens.This morning at church, knowing that the service was close to being over, i tried to get to the restroom because i had to urinate, even though i catherized at church before the service.I didn't bring a coat for cover up and embarrassing tried to get out because i didn't sense the leak, stain on my crotch.It's happened a few other times.My life has turned into a nightmare.I'm no farther advanced since the procedure on january 20th", and "every day i hope it will get better, knowing of the disaster everyday is quite depressing".
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