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MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM X; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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| Model Number 97800 |
| Device Problems
Energy Output Problem (1431); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Data Problem (3196)
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| Patient Problems
Device Overstimulation of Tissue (1991); Pain (1994); Discomfort (2330); Numbness (2415); Dysuria (2684); Paresthesia (4421); Swelling/ Edema (4577); Insufficient Information (4580)
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| Event Date 09/26/2023 |
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Event Type
malfunction
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Manufacturer Narrative
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Date is estimated; month and year are valid.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.The reason for call was patient says that their toes are kind of numb and says this started a month ago this is happening on both feet and worse if they scrunch the toes up.They are also swollen.They said that they have not made any adjustments because it had been working fine for them and helping their retention symptoms.During the call, the patient thought the ins had moved closer to the spine and was pressing on it, the patient used to be able to feel the ins, but no longer.Advised the patient to look for the longer incision and place the communicator just below it.That was successful and the caller reported that the ins actually did not move.Helped them connect to implant and turn stim down to 0.5.They will monitor symptoms now that change was made, and will follow up with managing physician.Advised the caller that they can also try turning the ins off completely if desired to see if that helps.The patient's medical history included patient says they have been wearing compression garments because their feet swelling.Patient mentioned that they have a friend who has interstim and that friend told her that if she (the friend) ever feels the stimulation in their feet, they turn it down and that is what resolves it for her.Additional information was received from the patient.Patient (pt) called back repeating a continuation of event previously reported in this case that has been getting worse.Pt reported they have been having problems with their toes hurting that got "very, very bad" by saturday.Pt reported this was three toes on their left foot.Pt stated this started about 2 months ago with swollen feet and swollen ankles.Pt stated their family dr did not refer them to their managing physician for the implant or that it had anything to do with it.Pt reported by saturday their toes were really hurting badly and their lower back has continued to hurt.Pt stated they have "other back problems as well".Pt stated they turned therapy way down to see if that had anything to do with it.Pt stated yesterday morning decreased to ".01" and the swelling went down, their toes stopped hurting and the part across their back also stopped hurting.Pt stated they turned therapy up to.05 this morning and their toes are "ok".Pt inquired about different programs and when to change programs if having this problem or if they should just keep therapy very low.Pt reported they are "just tinkling" and stated they are drinking water but they are not peeing as strongly as they did before.Pt stated purpose of implant is to help them to pee as pt stated implant is indicated for use for them for urine retention.Agent reviewed therapy/stimulation overview and expectations.Reviewed role of patient services.Agent redirected pt to their healthcare provider to further discuss symptoms and therapy changes.Pt stated their dr's office directs pt to speak to patient services.Pt initially stated they have not tried any other programs.Pt stated when they turned stim slightly up they "completely didn't hurt at all" and reported they have been hurting very badly for a month and every day got worse and reported hurting very badly by saturday so that's why they turned it down.Pt reported "they feel a little bit funny" at 0.5.Pt me ntioned again they had a friend who has the ins that has tried other programs.Pt inquired about recharger on website.Reviewed pt has non-rechargeable implant and reviewed purpose of recharger.Agent walked pt through how to connect with implant and how to change programs.Pt made a comment when connecting with their implant that "sometimes it's not easy" to find their implant.Pt initially reported getting device not responding that was resolved by repositioning communicator on pt's implant.Reviewed repositioning of communicator on pt's implant.Once pt connected with their implant, pt stated they were on program 4 and stated they did not know why as pt stated therapy was on program 1.Pt reported they thought they started on program 1 and "it jumped to 4" (pt did not clarify this statement).Pt confirmed therapy was at 0.5 which is where pt said they set therapy.Then pt reported getting "operation failed an error occurred while performing the operation please try again" when trying to connect to change programs.Pt pressed retry and following repositioning communicator, confirmed successfully changed programs.Pt mentioned in the past they had to use a mirror to see scar when placing communicator on implant.Reviewed programs general overview.Pt then stated the entire time since the surgery "it has just been on that one program at 1.5" and reported "obviously the 1.5 was too strong because for my back to suddenly stop hurting today" and reported their feet have been swollen for like two months and it was too high all that time.Pt increased stimulation on new program on the call and initially stated feeling "pressure" that pt described feeling more in lower buttocks area (confirmed they thought feeling pulling sensation in bicycle seat area).Pt confirmed not uncomfortable.Reviewed stimulation expectations.Pt later reported they thought they could feel stimulation in their toes again.Agent reviewed considerations to decrease stimulation.Pt decreased stimulation and when asked how stim felt pt stated it was "too soon to tell".Pt then later stated still feeling in toes.Reviewed consideration to continue to decrease stim.Pt decreased stim again and stated they will give it a little time.Pt will monitor stimulation sensation and symptoms.Pt stated they think they need to give it time.Pt mentioned the following relevant medical information: pt stated they are afraid of the urine backing up as pt reported "before i got it they had to take out 850 cc's that had backed up".Pt mentioned in original call that they did not turn stim down that much and stated they just turned it down to "maybe 1.1 or 2".Pt stated they do not think they decreased stim down to 0.5 as pt stated they think they were still at too high of a setting.Please note, agent had a difficult time following pt throughout call and made best attempt to document all relevant event information.Pt will maintain stimulation level and will continue to track symptoms.Pt will adjust stimulation as needed and will decrease stim if uncomfortable.Redirected pt to managing healthcare provider if issue persists/to discuss symptoms.Additional information was received on 2023-nov-07, patient (pt) called back repeating a continuation of event previously reported in this case.Pt stated they "did get my toes to quit so it was a big help" but reported now today "they are bothering me a little bit".Pt stated they were "still able to go" and they went a lot during the night.Pt stated it "worked a lot, almost too much during the night" pt stated they changed from program 4 to 5 but now their "toes are stinging again" so they wanted to make another adjustment but stated they can't figure out how to change programs.When asked, pt stated they have tried decreasing stimulation and stated they "did two of them on program 4" (agent unclear what pt was referring to by this).Pt stated yesterday they were able to change the programs and today they are not.Agent reviewed therapy general overview/expectations.Pt stated their toes are hurting so they want to change programs again.Pt stated they adjusted stimulation setting today and they were "doing ok" but they were not sure they would be able to go to the bathroom.Pt stated they went to program 5 and reported that is the program they had during the night and they have continuously decreased stimulation all day because their toes are hurting and now they want to change programs and can't get there.Agent reviewed how to change programs.Pt made a comment again that sometimes they have to retry when trying to connect with their implant because it's not in the right spot.Pt connected with their implant and stated therapy was on at program 5, 0.3.Pt reported their toes are still hurting and wanted to change programs again.Pt stated they think they need to experiment with programs rather than following up with their physician.Reviewed general overview of programs and redirected pt to their healthcare provider to further discuss programs and symptoms.Pt successfully changed programs on the call and stated they will start with stimulation low and "work their way up".Pt will monitor now that therapy adjustment was made.Agent redirected pt to managing physician to further discuss to issue.Pt expressed dissatisfaction that they feel [manufacturer] was not patient with them.Agent reviewed role of patient services vs pt's managing healthcare provider.
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