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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
Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Positioning Problem (3009); Insufficient Information (3190)
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| Patient Problems
Diarrhea (1811); Micturition Urgency (1871); Headache (1880); High Blood Pressure/ Hypertension (1908); Hyperventilation (1910); Incontinence (1928); Inflammation (1932); Itching Sensation (1943); Memory Loss/Impairment (1958); Nausea (1970); Nerve Damage (1979); Undesired Nerve Stimulation (1980); Neuropathy (1983); Pain (1994); Paralysis (1997); Rash (2033); Tachycardia (2095); Tinnitus (2103); Urinary Retention (2119); Visual Impairment (2138); Loss of Vision (2139); Burning Sensation (2146); Twitching (2172); Dizziness (2194); Dysphasia (2195); Urinary Frequency (2275); Numbness (2415); Irritability (2421); Shaking/Tremors (2515); Ambulation Difficulties (2544); Cognitive Changes (2551); Weight Changes (2607); Paresthesia (4421); Unspecified Nervous System Problem (4426); Partial Hearing Loss (4472); Cramp(s) /Muscle Spasm(s) (4521); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577); Insufficient Information (4580)
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| Event Date 04/28/2021 |
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Event Type
Injury
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Manufacturer Narrative
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Other relevant device(s) are : product id: 978b128, lot#: va2aqd2, implanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(4), ubd: 15-jul-2022, udi#: (b)(4).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 manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the patient complained of feeling the device at the lead insertion site, the ins site and the sacral area.They stated they had pain at the lead insertion site, pain at the ins site and pain in the sacral area.They also stated they were feeling stimulation in the feet and had spasms in both feet and they thought it was due to the device.The patient turned stimulation off and video called the rep on (b)(6) 2021 to show the spasms.The patient had significant toe flexion spasms in both feet while the device was off.They were being seen by a neurologist and was diagnosed with small fiber neuropathy.They did not believe the neuropathy was the cause of their flexion.On (b)(6) 2021 the patient was seen by their implanting physician who assessed the incisional sites.No concerns were reported they incisional sites had healed well.They had not had any falls and did not have any infections at the time.They physician could not explain the pain.The hcp redirected the patient to the rep to work on trying different programs to see if any would help with symptoms without causing additional spasms.The issue was not resolved at the time of the report.Additional information was received from the patient on (b)(6) 2021 they reported that they had the mri compatible new one put in (b)(6) of 2020 since then they have become numb in belly button down both of their legs on both sides all the way to my toes to the point where they cannot curl toes under and cannot spread them apart.They also have been hyperventilating every single day multiple times a day sometimes it comes in waves sometimes will have one episode and it will clear up in a few hours later get a new episode.They are also losing weight and all of the wires are moving and are sticking out of the body and there is a bump at the location of the lead insertion.The hyperventilation flares begin as a high tone hitch in left ear lose vision in left eye and muscles become constructed in their entire body.Patient further stated that the placement never seemed right and now with they want it removed immediately it's affecting their skin, it's giving them a red hue all over when in active flared affects their speech it affects, breathing and heart rate becomes elevated my blood pressure goes up wire sticking out, bulging out and the battery heal poking and their whole body is draining into their feet causing them to be numb and swollen and red they get random rashes all over the body and legs, arms, feet, face.Patient stated their whole body become completely contracted and become extremely itchy they lose vision <(>&<)> hearing in my left and ear.Patient further stated that they were having problems speaking.Patient stated on the day of the call that they would be having the interstim removed via surgery today sometime i'm currently in the hospital.They cannot use the stairs since they cannot curl their toe as it has become constructed and unable to bend.Patient went further to start that they had pain due to the device and is completely paralyzed and have constant tremors and twitching.Specifically my toes are killing me.And this headache it has been close to four months.It's giving them terrible heart palpitations t wave an st wave heart abnormalities, tremors muscle spasms twitching ,sweating even though my feet are freezing cold.They cannot even have it on a 0.1 amp, it goes straight to feet , toes and they become stiff and hard and painfully numb tingling burning itchy rash they get a red hue over them over my entire body.All the urgency frequency and pressure has returned to their body during urination and bowel movements.Patient started that they now have urinary retention urgency frequency pressure as they can't empty completely , can't start the flow correctly it's a lot of starts stop in the middle.Patient stated they wet themselves in the middle of the night without knowing.Patient further stated that their pulse is constantly running high blood pressure is between normal and extremely high extremely disappointed with the new mri compatible interstim as its causing blisters on the inside of mouth on their tongue and get in the way of eating which i can barely do anyways since the new device was implanted (b)(6) and maybe causing irreparable damage to my nerves vision and hearing, headaches and overall body spasms in terms of the muscles tremors twitching itchiness histamine r elease difficulty breathing difficulty speaking.No further complications were reported/anticipated at this time.
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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 a manufacturer representative (rep).The rep reported that the patient had their device explanted on (b)(6).The device had been discarded.The patient had multiple diagnoses and the physician did not believe the issues the patient experienced were related to the device.The device was off the majority of the time and the patient still experienced symptoms.The rep also reported they called the hcp to confirm information and the hcp said the device had been sent to pathology and no pathology issues had been found.It was noted the patient was in possession of the device at the time of the report.It was unclear at the time if the device would be returned, but the rep had asked the hcp request it to be sent back for analysis.
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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.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 a manufacturer representative (rep).The rep reported that the patient did not return the device.Additional information from the patient report that they had a new device inserted in 2020, they were also given a 5 day course of bactrim at that time.Immediately after they started having nausea, diarrhea, loss of appetite, muscle atrophy, mood changes, aggression, fluctuations in blood sugar, increased heart rate, hypertension, tinnitus, headache, vision loss, and lightheadedness.Due to these side effects they had emergency surgery to remove the device, they were uncertain if the side effects could be attributed to the bactrim, the device, or both.Since device removal, the flares and symptoms had changed.The more prominent symptoms were now headaches, tinnitus, loss of vision and swelling of the lymph nodes, fever.They had lost almost 60 pounds without trying in the last year.There red blood cells were elevated.[concomitant medical information was listed as: titanium hooks in hips, gabapentin, soma, trintellix, folic acid, hydroxyzine, vaginal valium suppositories, lidocaine 5% patch, viscous 2% lidocaine, urojet, promethazine suppositories, uribel, azelex cream, prilocaine/lidocaine, motrin 600 mg, vyvanse, ritalin, epipen, magox, vitamin d3, biotin, selenium, zinc, vitamin b12, vitamin c, omega-3, nadh, icy hot gel, accu-pressure, cromolyn, sodium nasal spray, pepcid, claritin, omeprazole, xyzal, boric acid suppositories, cbd tincture].
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Event Description
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Additional information was received from the patient.They reported that their device was implanted for ic.Patient said the device was implanted and it was fine and helped a bit.Patient said the device helped with urgency and frequency.Patient said their problems are coming back.Patient said the newer device failed completely, patient went to the er and was told the device needed to be taken out and the patient was rushed to the or.Patient said the whole system was removed on (b)(6) 2021.Patient said the wires were sticking out but didn't break the skin.Patient said they could see the wires but they didn't break the skin.Patient said the device was not helping their symptoms.Patient said when the battery started failing, patient said it was reprogrammed several times, they started to get strange symptoms like perception issues, cognition, visual impairment, hearing loss, ringing in ear, constant head aches, feet and arms numb and tingly and still are today.Patient also noted loss of coordination in terms of walking, short term memory issues and they can't drive.Patient was diagnosed with small fiber neuropathy.Patient had a mri of orbit in the brain, patient said, for their age, they said it was normal.Patient said they had a patch test which showed are highly allergic to metal.Patient said these symptoms maybe caused by a nickel allergy.Agent reviewed material that can come in contact with human tissue and reviewed treatment, next steps will be up to a hcp.Patient said they have the device that was removed and would like to send it back for analysis.Agent reviewed patient services will look into the process and get back to the patient.Agent did not ask about the circumstances that led to the reported issue.The patient was redirected to their healthcare provider to further address the issue.
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Manufacturer Narrative
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Continuation of d10: product id 978b128, lot# va2aqd2, implanted: (b)(6) 2020, explanted: (b)(6) 2021, product type lead.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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