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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
Failure to Deliver Energy (1211); Pocket Stimulation (1463)
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| Patient Problems
Micturition Urgency (1871); Incontinence (1928); Undesired Nerve Stimulation (1980); Pain (1994); Burning Sensation (2146); Distress (2329); Discomfort (2330); Insufficient Information (4580)
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| Event Date 01/24/2023 |
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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 urinary dysfunction/sacral nerve stim.It was reported that since the device was implanted, they have not had therapeutic benefit.Caller stated they have already been back to the office twice to meet with the manufacturing representative (rep) regarding the issue and they think they will have to go back again on monday.Caller stated they tried calling the rep several times again and they have not gotten a response.Caller is feeling frustrated and disappointed that they have to keep going back in to have this checked.Caller stated that the previous two implants worked great.Caller stated they have had the therapy on programs 1,2 and 3 but when they went up they felt it burn in the vaginal area so they turned it back down a notch.Caller stated that when it is down so low it doesn't help the urination problem.Caller stated they didn't try the higher programs because 3 was too strong so they didn't want to go higher.Reviewed the difference between intensity and program numbers.Walked caller through adjusting stimulation from p3- 0.1ma to p4- 1.3ma.Patient will maintain stimulation level and will continue to track symptoms.Confirmed stimulation in bicycle seat area and comfortable.Redirect to doctor if issue persists.Additional information was received from the patient.The patient reported ongoing therapy concerns.They have a follow up appointment with their managing physician next week, however they cannot find their communicator.Agent emailed repair for a replacement communicator.Additional information was received from the patient.Patient said the ins is still not working and they are going through 2 pads a day.Patient said they can't control the urine, it just comes rolling out of them.Patient said they urinate often and urinate on themselves.Patient said they saw a medtronic rep at the hcp office on friday (name asked, unk) and they changed the program.Patient said they called their hcp and the pa told them that it takes 6-7 weeks for the body to adjust to the stimulator and patient said they don't agree because this never happened with their previous stimulators.Patient said when they changed the program, it didn't help with their symptoms and they also were feeling vibration in the vaginal area that was bothering them.When reviewing therapy optimization options, patient said they didn't want to increase stim on the current program because they didn't want the vibration to get worse and said it will be constant.Patient said uncomfortable vibration has been going on, off and on, since implant.Patient said the pa called and said they want to do an x-ray to check the lead wire.In the meantime, patient said they wanted to try changing programs.Helped patient successfully connect external devices to ins and patient changed programs.Patient increased stim to a comfortable level and said they could feel slight vibration at 1.9ma so they moved it down to 1.8ma and said they will monitor symptoms until they get their x-ray.Additional information was received from the patient.They reported that the device has not worked.Patient said their symptoms are worse than they were before getting their 1st device.Patient has gone to the urologist 7 times.Patient said they know something is wrong because the previous 2 devices were successful.Patient said they have seen 2-3 reps in the last 6 months.Patient said there is a mistake somewhere.Patient said they have had the device checked and been told the device is working but it is not helping the patient's symptoms.Patient said their symptoms are worse than ever before.Patient doesn't know why all of a sudden there is changes.Patient said their urine control is worse.Additional information was received from the patient.The patient called back and reiterated previously reported information.They stated their urologist who implanted their device told the patient they just implanted the device, so they worked with the urologist's physician assistant (pa), the patient stated the therapy only helped for about 6 weeks before it stopped helping and they'd seen the pa 3 times but the pa couldn't get it adjusted to a level that helped the patient, so the pa told the patient to call medtronic.Patient services reviewed therapy expectations with the patient and guided the patient in connecting to their settings.The therapy was on.The patient increased the stimulation but they felt it at the implant site.The patient backed the stimulation off a bit from that level.They didn't feel the stimulation in the bike-seat but they stated they wanted to leave the stimulation there and monitor their symptoms.Patient services redirected the patient to follow up with their health care provider (hcp)/pa about where they felt the stimulation and their therapy concerns.
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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 are still peeing all over themselves and are wanting to make an adjustment.Pt states they are having trouble connecting to the implant, however.Pt stated they initially were seeing the not found message.After switching communicators, they were seeing no device.The agent had to close out of all running apps and toggle bluetooth off and back on.Pt stated at that point they were seeing device is not responding.The serial number of the communicator was (b)(6), and they noticed this issue within the last month.Pt mentioned they had a few implants in the past and had another communicator.The agent had pt try the other communicator, and pt was successful at connecting on the first try.Pt increased stim to a comfortable level and will continue to monitor symptoms., (con): additional information was received from the patient.They reported that the urge was frequent and continued to have leakage.I have been to their hcpc four times since the third implant but have found it more detailed.Help.The patient stated that this is their third attempt, and it is very unsuccessful.They will continue to change and adjust the settings as needed.Pt states they are still peeing all over themselves and are wanting to make an adjustment.Pt states they are having trouble connecting to the implant, however.Pt stated they initially were seeing the not found message.After switching communicators, they were seeing no device.The agent had to close out of all running apps and toggle bluetooth off and back on.Pt stated at that point they were seeing device is not responding., and they noticed this issue within the last month.Pt mentioned they had a few implants in the past and had another communicator.The agent had pt try the other communicator, and pt was successful at connecting on the first try.Pt increased stim to a comfortable level and will continue to monitor 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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Continuation of d10: product id tm90g0, serial# (b)(6), product type accessory.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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Patient repeated therapy information, see call summary.Patient requested assistance about switching programs.Reviewed information and patient successfully switched to a different program.Reviewed therapy information and general programming guidance with patient.Patient adjusted setting and then decreased as said felt pain which subsided when they decreased the setting.Patient to monitor symptoms, patient mentioned first device was replaced because needed mri and second implant was replaced as patient had difficulty reaching the implant to recharge the implant which made it difficult to recharge.Patient called back on (b)(6) 2024 and reported that the therapy continues to not help their urgency.Patient states they noticed this about 3 weeks ago.Patient states they've tried several programs but they don't think they've tried the right one yet.Patient confirmed increasing on each program that they've tried to the point, that it becomes uncomfortable.Patient inquired if there is another program they should be trying.Agent reviewed option to continue trying other programs the patient has left to try and to continue monitoring symptoms.
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Search Alerts/Recalls
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