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MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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| Model Number 97810 |
| Device Problems
Intermittent Continuity (1121); Display or Visual Feedback Problem (1184); Electromagnetic Interference (1194); Migration or Expulsion of Device (1395); Energy Output Problem (1431); No Device Output (1435); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Vibration (1674); Malposition of Device (2616); Charging Problem (2892); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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| Patient Problems
Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Nausea (1970); Undesired Nerve Stimulation (1980); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); Electric Shock (2554); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 11/01/2021 |
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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 unknown indications for use.It was reported that the patient has suspected retroperitoneal bleeding after 1 year as a result of failure to follow up by physician.Patient noted they have been telling them something was wrong and reporting symptoms & possible malfunction of device.The doctor returned their call after 3 months and suggested it might be patient's "perception." patient has an appointment with a new specialist on nov 1 for a suspected diagnosis.Patient noted "if you are going to pudge these devices as money making devices you need to ensure you have an emphasis on patient care follow up." patient indicated that they never saw that surgeon again although they left multiple messages for months.At one time their practice manager told the patient that they didn't know enough about the device to help.Patient may now have a pending health emergency from nothing more than a physician/surgeon who does not want to follow up or provide patient care.
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Manufacturer Narrative
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Continuation of d10: product id 978a128, lot# va2fzmr, implanted: (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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Event Description
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Additional information was received from the patient.They reported that on (b)(6), 2021, they were getting shocked when the microwave turned on; therapy was speeding up when the controller charged to 100%.They called hcp who didn't call back, then called manufacturer who advised them to turn off controller and to turn back on.It functioned well for 3 months and then started erratic pattern and continued erratic issues.If the controller is charged to 100%, they will have what feels like continuous electrical current down left arm and leg.It often goes on high speed if they use their mattress, vibration function; it seems affected with continuous vibration, airplane or car.They can only charge to 90%.The cause is unknown; their hcp returned their call after 3 months, and they went to another specialist who took an x-ray, which said that the lead wire is pointed slightly up instead of down and may be the cause.They called original hcp who did not return call, and people from the office directed them to manufacturer.The hcp who did the x-ray told them it was programmed too high and they should start by setting it on 2.This was programmed by a surg.Tech right after they got out of recovery.The unit worked well by turning off for reset until long airplane trip.After many other small issues, the only resolution attempted was by a rep when they called.They have an hcp appointment on dec.16th.The patient also used electrical engineer who suggested the controller was possibly malfunctioning depending on charge load.
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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 the cause of the lead wire pointing slightly up was not determined.To resolve the issue, they did more x-rays and couldn't find anything else.They have an hcp appointment march 3rd to have programmer looked at and it adjusted.The issue has not yet been resolved.The cause of the erratic issues and therapy speeding up was not determined.It seems to be usually affected by vibration; the generator is close to the skin.To resolved the issue, they changed their doctor, had more x-rays, and march 3rd appointment scheduled.Hcp told them it was programmed at too high of a setting.The issue has not yet been resolved.The cause of only being able to charge to 90% was not determined.The original programming was on too high, set at 5.They followed recommendation to turn down to 2 and then adjust up if needed.The second opinion hcp gave them the programming info.It has made it tolerable, and the hcp understood more how it functioned but no longer uses manufacturer unit, so they had to change hcps.The patient has contacted the hcp who manages the device, and will meet with manufacturer representative to help with programming.Since the second opinion hcp told them to start on '2 setting' and adjust if needed, they don't have the issue but they no longer use 5.The patient stated they read all the books but no where does it mention what to do if the hcp has failed to program it correctly and has no training on the unit.
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Event Description
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Additional information was received from the patient.When asked to clarify the statement "have been telling them something was wrong and reporting symptoms", they stated "this unit may be defective however the programming was never addressed.They set it on 5 after surgery and then told me they knew nothing about unit.It is hyper sensitive to any vibration and too near top of skin".They asked when they first noticed the issue, they stated 1 month after surgery then 3 months then any xray or plane since oct 2021.When asked to clarify the statement regarding "possible device malfunction", thy stated "i called and called with each incident the doctors and staff never returned the call.Almost a year later and 3 months after last msg.They returned the call and ask it if was 'just my prescription'".This was not caused by normal battery depletion.The cause of the malfunction was not determined.They stated "doctors and staff never bothered i called company to get help hyper sensitive to vibration, can function well and then stop, regular xray with it off causes it not work for 3-5 days or to just vibrate".When asked what steps were taken to resolve the issue, they reported "changed doctor, got new xrays, lead may be positioned wrong, unit too near top of skin, charge felt in wrong place".The issue was not resolved but no further action will be taken.
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Manufacturer Narrative
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Continuation of d10: product id 978a128 lot# va2fzmr.Implanted: (b)(6) 2021.Product type: lead.Section d information references the main component of the system.Other relevant device(s) are: product id: 978a128, serial/lot #:(b)(6), ubd: 2023-03-29, udi#: (b)(4).B3.Date is estimated; year is 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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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.Patient reported that they didn't know if the medication would have relieved their symptoms as they never tried it.They stated the implant complications were that it appeared to work well and all symptoms were relieved for 90 days.However 3 months later, there was a shock from the microwave which the unit seemed to be reacting to the vibrations in the car by changing speed experiencing as stronger impulse or continuous impulse until it was turned off.They also stated that mammogram, they had it set on suggested function and then turned off.But then it would not turn on again for several hours and that ran at higher speed until it was turned off.Four months later it continuous was running after 3-hour plane trip.It had no reaction on the first flight and went on a continuous stimulation cycle as soon as it was turned on after their return trip.The unit had been turned off.It also reacted to our mattress vibration function by continuous stimulation had to be turned off and then restarted.Mattress function has not been used around it since that incident.Exercising was also an issue.With any run/jump or continuous movement it starts continuous running again.Tai chi isn't possible because pain develops in their back near the site.They have called manufacturer, and it was suggested to turn off the unit, wait for a bit and turn on again anytime it starts reacting to something.Patient turned it off anytime they would be sitting in area with continuous vibration.This has worked for the most part.Patient has sought second opinion who advised that the program set at s was too high and gave them a way to set it at lower stimulation level.That worked until it didn't.Recently while sitting in their car a large diesel truck pulled in next to them and left engine running.The unit picked up the same vibration pattern and patient had to turn off.They also have the occasional blood in urine after charging the internal battery for past two months.In january they developed a uti with blood in the urine.They had continuous stimulation after a walk/fast walk exercise session.The charging variance between the recharger and the controller: the recharger battery check is always 10% lower than the controller reports its status.Conversely when patient recharge the internal unit it appears to be overcharging it and the current or impulse can be stronger than the setting.If charged to 90% patient will get shocked when starts up again.Now patient never charge it over 80%.One time patient was shocked enough that the impulse ran from their left side down to their foot.Bleeding in urine afterward and nausea.One week ago, patient was shocked enough for the current to run from left side to foot again.Patient was not near anything that might have affected the unit.This time the shock left patient's left leg and left arm sore, giving them a headache, and experiencing nausea.The night before, patient woke up to steady vibrations.And when they c hecked to see if the mattress accidently got turned on.It was not.The unit was trying to start.It was turned off.Patient felt odd sensation where the unit was and felt it to see if i could tell what it was.Patient could feel the whole unit very close to the surface as if it was pushing on the skin and a piece that felt like a lever or something.When patient pushed it over it moved away from where it was and stopped.The unit was off, and it has been off for several days.Patient stated that for long term, they notice their balance isn't as good since they have had the implant.Their left leg and foot are not as flexible as right side.And for lifestyle/wellness issue, for years patient have worked out 3 days a week, use light (sib) free weights and run through tai chi 3 kata sets.Because their thyroid doesn't work well their weight rarely changes but their overall health has been good.Now patient feel stressed not knowing what to expect from the unit functioning and for a year the only solution that was offered was turn if off and then turn it back on, reduce all physical activity or call someone at manufacturer.It's been a negative lifestyle change for patie nt.When patient agreed to the neuro stimulator, patient only had bladder retention and occasional bowel urgency issues.Now patient feel worn out from coping with a piece of erratic equipment.
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