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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); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Diarrhea (1811); Incontinence (1928); Muscle Spasm(s) (1966); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Anxiety (2328); Complaint, Ill-Defined (2331); Electric Shock (2554); Lethargy (2560); Constipation (3274)
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| Event Date 07/15/2019 |
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Event Type
Injury
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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 consumer regarding a patient who was implanted with a neurostimulator (ins) for gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stim, specifically urinary incontinence.It was reported that the patient was concerned and worried because they will go into the bathroom, feel they have to go, but then don¿t; they have not been peeing since implant.It was noted that they hadn¿t drank much, but their normally wear 15 pads, and had only used 2 today, to stay fresh.They had tried calling their healthcare provider but had not gotten a response and they were getting scared.Troubleshooting found that stimulation was on, on program 3 at 0.7v.They increased to 0.8 and felt stimulation in the correct area.They mentioned that they were feeling stim jump in their butt cheek at 7 before, but at 8 it was comfortable.They increased to 9 and felt stim jumping in their butt so they turned it down to 8.It was also reviewed that if they thought therapy was working ¿too good¿ on 0.7, another option is to decrease stim as needed.It was noted that they will try the new setting and follow up with their healthcare provider if the problem does not resolve.There were no device issues reported, and no further patient complications are anticipated or expected as a result of this event.
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Event Description
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Follow up information received from the manufacturer¿s representative reported that they were unable to make the sept.5 appointment and did not know if the physician had addressed the lump on the patient¿s spine.The patient had an appointment with the implanting physician on (b)(6) 2019 at which time they issue would be addressed.They also noted that the patient had been speaking with someone in the manufacturer¿s patient services that were helping them with their device.There were no further complications reported or anticipated.
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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 who reiterated all the same information that she reported in original call.Patient said that she has tried all four of her programs at this point butcontinues to have same issues: is still peeing all over herself, toes/butt cheek will jump around if she increases stimulation up past 6/7 v (pt noted she had to take valium because that made her a nervous wreck), still has diarrhea/constipation that continues.Pt said she talked to her primary care doctor about the diarrhea and was told to take metamucil, pt said she didn't poop for 2 days but then got on track but then changed her program and that turned her world upside-down and bowel schedule was off track again.Pt said she was changing her programs every 24 hrs, patient services reviewed changing programs was to be at the hcp/clinician direction and reviewed difference between increasing amplitude vs chang ing programs.Pt said she is going to change back to the original program she was on and increase stimulation to a comfortable level.A rep was going to meet the patient at hcp office on 2019-aug-16 to add new programs to her device but wasn¿t able to due to a death in their family, and patient wanted to reach the rep regarding their next hcp appointment on 2019-sep-05.Patient services sent an email to the rep stating patient reported she had tried all four of her programs but hadn¿t yet had success with her bladder and was additionally having bowel issues.The rep responded to that email and stated they had spoken with the patient and were trying to coordinate a meeting at the hcp office.On 2019-aug-30 the patient called in again was very frustrated with the device and the hcp had not called her back.Patient reports they have a lump on the spine at the lead implant site since about 3 weeks post implant.Pt has a doctor¿s appointment scheduled on sept 5th 2019 @ 9:30am.Pt states she had a lump on the spine where the leads went in.Pt states the lump was about the size of a knuckle and it was real hard.Pt states she called the doctor and they told her that it was normal.Pt states the next day it was no longer hard but spongy.Pt states she can still feel the lump, but it is not hard or swollen anymore, but she can still feel it is there.Pt again reported the previously reported issues and stated they have hirschsprung's disease and since implant have had issues with horrific diarrhea and then constipation.Patient services emailed the rep again to remind them of the sept 5th hcp appointment, reiterated that patient was frustrated with the therapy and isn¿t sure what she should be doing, and stated the patient¿s trial went very well.
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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 received from the patient reported that they were ¿still leaking and peeing all over the place¿ and was ¿holding her urethra all the time¿.The patient indicated that this had happened since the start.They stated that they were retaining the whole time and was dripping.It they would lay down, the leaking stops and the minute they stood up they did not have control.The patient requested assistance with adjusting the stimulation.The patient was on program 3 and when they went up to 0.08, their toes curled under so they turned it down.The patient then changed to program 1 and increased to 0.07 but it was felt too strong so they went down to 0.06 where they felt itin the butt cheek.This was described as little shocks.After some time on the new setting, the patient felt like their "whole back of thigh is jumping".It was advised they lower the stimulation as needed.Therapy expectations were reviewed with the patient.They were going to monitor their symptoms with the change that was made.In addition, the patient r eported that their ¿spine got swollen up¿ where the wires went in.This occurred ¿2 and a half weeks: after the procedure (2019).They notified their doctor and was told them this was part of the healing process.They also reported that they had diarrhea after im plant of the device.Their healthcare professional (hcp) recommended using metamucil and the patient stated this was helping.The patient also mentioned that they were not well trained (inadequate training) and came home feeling the effects of anesthesia.They did not know how the programs and how increasing/decreasing the stimulation worked.There were no further complications reported or anticipated.Follow up information received from the patient on (b)(6) 2019 reported that their issue was not resolved.They noted that there were issues with colorectal diarrhea but they were working with issue using metamucil.There were no further complications reported or anticipated.
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