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MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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| Model Number 97810 |
| Device Problems
Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Material Deformation (2976); Positioning Problem (3009); Insufficient Information (3190)
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| Patient Problems
Cellulitis (1768); Fever (1858); Swelling (2091); Post Operative Wound Infection (2446); Electric Shock (2554); Fluid Discharge (2686); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 09/04/2020 |
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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 via a manufacturer representative regarding a patient with an implanted neurostimulator (in s) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that they saw the patient for the first post op visit (10 days post op) and were trying to charge the patient's device.Initially they saw an error code 3167 and held the power button down to reset the recharger, which resolved the issue briefly.They put the recharger over the device, and the recharger attempted to charge for about 10 seconds and then lost connection.They attempted this about 4-5 times, where the recharger connected briefly for about 10 seconds and then the recharger went to searching mode.They reported that the power button was now red.They saw an error code 1707.The agent reviewed the error code.The recharger power bar was solid green lights, all 3 bars.Technical services suggested to reset the recharger.The recharger was successfully reset and they caller was attempting to recharge again.They briefly saw an error code 'npp', but the caller could not capture the complete error message as it popped up and went away quickly.The caller reported that the ins pocket site was still swollen.They were recharging through clothing.Technical services suggested not charging for now and re-evaluating.The rep could feel the ins under the patient's skin.They reported that the patient's pocket site had not healed.The pocket was possibly infected, the ins pocket appeared swollen and red.The patient indicated that there was some discharge coming from the pocket.The patient also had a mild fever (99.9).This was their 3rd visit to their physician's office that week.The patient had started an antibiotic and a topical ointment yesterday.The patient's husband said that the ins pocket site had shown slight improvement.The patient had an appointment scheduled with their physician the coming tuesday.
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Event Description
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Additional information was received from the rep on september 9th: the cause of the 3167 error seen was not determined.On september 14th additional information was received from the consumer: patient reports she ended up with a cellulitis infection around the incision, and stated the infection is just a skin infection and there was no swelling.The patient also stated the ins is at 0% battery and the ins will not charge.Patient said they have tried to charge the ins about 50 times in the last 10 days, has tried to charge with underwear on and underwear off and has repositioned the recharger all over.Patient said the recharger will connect with the ins for a very short time then the recharger will go back to searching for the ins.While the recharger is searching for the ins the patient gets zapped, feels shocking while trying to connect.Patient said they have seen code 1707 and the patient thinks the other code they have seen is 4101.Patient said the communicator connects the ins with no issues.Patient met with a manufacturer¿s rep in person for trouble shooting and the issue was not resolved.The rep recommended the patient call in and have recharger replaced, so no further troubleshooting was done, and the patient was transferred to repair to have recharger and docking station replaced.
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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 was received from a consumer via a manufacturer representative.It was reported that the patient had the 1707 message with the initial recharger as well as multiple 3167 codes.The wireless recharger was reset multiple times.The patient received a new recharger and had not seen the 1707, but had seen multiple 3167 codes with resetting of the recharger not resolving the issues.The rep tried charging the ins normally with the patient's new recharger, but the recharger constantly searched for the ins with only brief seconds, where the wireless recharger had the ascending tone indicating it had found the ins.The said it would go right back to searching with constant beeping.Charging was attempted with the communicator off, and the handset not in use.The rep had the recharger right over the ins and the recharger beeped like it found the ins and the patient felt a shock that penetrated from the recharger into the butt cheek, where the ins was and it felt like static electricity multiple times.Technical services had the caller check the ins with the clinician app to see if the ins was on/off and the rep then saw por (ins off) on the clinician app.The patient mentioned then that they saw the por on their patient app last night.The rep then reduced the speed/warmth from 2 to 1 on the recharge app and attempted to charge again with the recharger over the patient's dress, shirt and underwear.There was no shocking, but the persistent searching continued with intermittent ascending tones that lasted only seconds.The recharger then turned orange and the 1707 message showed on the patient's recharger app.The rep attempted clinician reset mode and once that was complete, the recharger did not go into the open loop charging, but rather went into the same searching for device cycle.The rep noted that initially the ins seemed easy to palpate, but at the end of the call, noted that it didn't feel like they expected it to and that they didn't feel the whole micro.They could only feel either the header or the bottom end.The rep tried charging in a variety of angles with no success.Technical services advised imaging and redirected the rep to mobility to retrieve recharge and ras logs.Technical services reviewed and saw a number of instances of the 1707 that occurred early in the recharge session.There were a number of times that 'good' coupling was achieved, so they believed it should be possible to charge the ins.Technical services reached out to the rep with a list of considerations when charging/troubleshooting again with the patient.
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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 an healthcare professional (hcp) and manufacturer representative (rep).The rep reported that the patient's ins pocket had been revised.The rep observed a por that was most likely low battery por from a few weeks ago), but was able to do an impedance check.During the procedure it the rep and doctor saw that the ins had rotated in the pocket and said it was 'almost vertical' in the pocket.According to the rep, the ¿physician agreed that the pocket was too large and device migrated¿. during the case, the ins was moved to a shallower position, parallel to the skin and with an appropriately sized pocket.This worked.They used a sterile bag over the recharger and were able to charge with excellent coupling in both recharging speeds.The ins battery displayed 10%.Due to time constraints the session was terminated.This confirmed that the issue was primarily positioning issue with the ins in the pocket.
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Event Description
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Additional information was received from a consumer via a manufacturer representative.There was a meeting arranged with the patient, rep, technical services and engineering.The patient's ins was discharged.The external equipment was charged and available.The patient was using the 2n recharger that they had received.They were able to feel the long axis of the ins in their body.The patient and their husband were walked through positions for recharging the ins with 1 inch from the center position on level 1 and half an inch from the center positions on level 2.The patient's husband kept the recharger in each position for 30 seconds.The patient repeatedly saw 'searching' on the recharger app and was not able to get a good connection.The patient was getting 'zapped', which they described as similar to static electricity but worse.They reported the zapping was greater on level 2 and noticed it would start about 20 seconds into each position.They still felt zapping over 2 layers of clothing while the recharger was in the belt on level 2.The patient could not tolerate the zapping for long term and had to stop the recharging attempts during the visit.They used a spoon to get the recharger into metal detect and saw a range of 2-7 after placing it on the ins.This did not change recharging from searching.They reported that they had tried recharging laying down, standing, leaning forward, with the belt and over 1 or 2 layers of clothing.They had x-rays in the past, but the physician did not get any information from them because of the angle they were taken.The patient had an appointment scheduled with their managing physician on (b)(6) 2020.Technical services reviewed that the next steps would be to talk with their doctor about the ins position related to recharging.
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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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Correction in h6: after further review, device code a071302 and patient code c50541/e2104 do not apply to this report.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 from the patient.They reported that while recharging today was having difficulty connecting and received the code 9176 twice.Patent said that the code also said to contact clinician which patient did and was redirected to contact patient services.Patient said that the code is no longer on the screen and believes that was the correct numbers.Patient services agent consulted with technical services agent and they were not able to pull up this code however will continue to research.Patient services agent reviewed information with patient and patient said that they have been troubleshooting and has connected and has excellent connection and is recharging.Patient services will provide update to patient when more information is known.
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Event Description
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Additional information was received from the patient.They reported that after revision surgery on (b)(6) 2020 where the leads were no longer coiled in front of the ins and tucked in the pocket they no longer had any issues with shocking.If the patient charges on bare skin, they will get a little shock but feels nothing if charging over underwear or barrier.Patient charges in a recliner without the belt and gets excellent connection.Prior to the revision no matter how they charged, they would get shocks.The patient always charged with stim on and pressure did not change shocking and location of the recharger did not change shocking.
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Manufacturer Narrative
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Continuation of d10: product id: 978a128, lot#: va27gxd, implanted: (b)(6) 2020, product type: lead, ubd: 2022-02-19, udi#: (b)(4).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 an healthcare professional (hcp) and manufacturer representative (rep).The rep reported that the cause of the lead was "coiled in front of the ins" before the revision was undetermined as per hcp.The lead was placed behind the ins at implant.The patient's post-op wound infection, swelling, fluid discharge, cellulitis were all fully resolved per hcp.
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Manufacturer Narrative
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Continuation of d10: product id: 435135, serial# (b)(6), implanted: (b)(6) 2009, product type: lead; product id: 435135, serial# (b)(6), implanted: (b)(6) 2009, 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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Manufacturer Narrative
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Correction, device code a0406 was added.Section d information references the main component of the system and other applicable components are: continuation of d10: product id 978a128 lot# va27gxd implanted: (b)(6) 2020 product type lead ubd: 2022-02-19 udi#: (b)(4).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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Other applicable components are: continuation of d10: product id 978a128 lot# va27gxd implanted: (b)(6) 2020 product type lead ubd: 2022-02-19 udi#: (b)(4).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 an healthcare professional (hcp) and manufacturer representative (rep).It was clarified that the hcp had used the original pocket from the previous larger implanted device.
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Search Alerts/Recalls
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