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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); Unintended Collision (1429); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Unstable (1667); Charging Problem (2892); Communication or Transmission Problem (2896); Unauthorized Access to Computer System (3025); Insufficient Information (3190)
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| Patient Problems
Device Overstimulation of Tissue (1991); Pain (1994); Electric Shock (2554)
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| Event Date 12/14/2021 |
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Event Type
malfunction
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Manufacturer Narrative
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Event date is approximate.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 dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the patient reported a coupling issues with their recharger and their ins.Pt stated on (b)(6) 2021 they were trying to recharge when their recharger would not stay connected to their ins.Pt stated this is the first time they have had issues trying to recharge.Pt mentioned they recharge every sunday.Pt video called their hcp to troubleshoot this placement issue this morning, (b)(6) 2021.Pt stated they have tried many positions and replacing the recharger, but they will try to replace their recharger so many times the recharger will go inactive.Pt mentioned they had dropped their recharger off their desk.Pt also mentioned they had recently lost some weight.Pt also mentioned they had experienced a fall about a week ago, and their back fell on a rock.Pt stated they had noticed their ins may have shifted and they noticed some pain at their pocket site while laying down since then.Pt confirmed the pain has decreased since the fall.The following troubleshooting was performed: suggested pt lean forward and cross their legs, pt palpated for ins and noted they could only feel one side, placing comfortable pressure on the recharger, tightening their belt to help keep their recharger in place.Pt was able to have another person assist them with placement and adding pressure while on the call.Pt stated their ins battery is currently at 50%.The issue was not resolved through troubleshooting.Pt will continue to try readjusting the placement of recharger to establish a connection.The patient was redirected to their healthcare provider to have pt's implanted system checked and further address pt's recharger placement.
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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 urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor.It was reported that the patient (pt) was having difficulty with recharging, they can connect to their implant for only about 5 seconds and then the recharger will disconnect again.The pt mentioned that they get an electric shock when trying to recharge, also the recharger tone appeared to be getting more "dim." the pt met with jared greer a manufacturer representative (rep) today and they suggested recharger replacement.They pt said they can feel all corners of the implant and device is less than a quarter inch deep.They tried repositioning every section of the recharger over the implant but the result was the same.The issue was not resolved through troubleshooting.An email was sent to the repair department.On 2022-01-21 the patient called back to request fedex tracking info.Provided fedex tracking number and relayed the package is out for delivery by 4:30pm today.On 2022-01-21 the patient called saying they got the recharger and can't pair it.She said she got an error code of 401 or something like that.Was walking the patient through the steps when we lost connection.Called patient back two times and got voicemail.Left message for her to call back.On 2022-01-21 the patient called back.Patient services assisted the patient and connected the recharger to stimulator.The patient had 0% charge.They also had their arm in a brace and was having a hard time.Error code 1707 came up.Cleared error code 1707.Charge 10%, excellent connection and then lost the connection right away.The pt kept loosing connection.The patient was bent over.They can't feel the stimulator really.Can't really see or feel the implant.Patient services recommended if they can't stay connected to the recharger, to follow up with doctor to asses.Additional information was received from the patient.They reported that the patient called back repeating the same information.The patient is claiming that when a lady comes to her house that is tech savey she get's the patient's device serial number to pull up on her tablet.Caller is claiming this lady hacked her device and turned it off.She said, the issue started in november 2021 and progressed until the whole thing shut down.Nothing was paired together anymore.Charged everything up.Had to pair the recharger to the phone.Had to pair the communicator to the phone and then pair to the stimulator.She paired it up herself and that worked fine.Patient had no problem hooking up and charging.All of a sudden device was not working.She is calling doctor's office.She is stretching her body to get her device to charge.Patient was getting electrocuted (started in end of november 2021 ).Then stimulator shut down completely and device wasn't working at all.Called doctor office and talked to nurse.Told to talk to medtronic and technician.Patient was going back and forth with doctor and tech to see what was going on.She got it up and working herself.She turned stim on and it was on full power.Once turned it on it was on the highest setting it could go on.She was screaming and yelling.She had to turn the stimulator down.Patient talked about getting shocked when she was using the belt to recharge.She said, she wasn't using clothing between the recharger and her skin.Called technical service agent and reviewed there isn't a way for someone to hack into her device remotely.Patient would need to have communicator over her stimulator and they would have to have the micro my therapy application on their device.Explained it is not really feasible.Patient claims her device is helping her.Patient wants action taken on these people and wants medtronic corporation to support her.She said, she read on the medtronic cooperate website some people are having problems with the pacemaker and people are holding them ransom.Telling the patient if they don't pay them money they would shut their device down.
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Event Description
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Additional information was received from the patient.They reported that they had cut their charging cord and cable up because they were paranoid of their neighbor.They thought the neighbor had someone mess with patient's cords to get back at them.Agent sent email to repair and walked caller through how to connect handset and communicator to their stimulator.Patient was able to successfully connect.
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Manufacturer Narrative
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Continuation of d10: product id hh90p01 lot# serial# (b)(6) implanted: explanted: product type mobile platform product id tm90p01 lot# serial# (b)(6) implanted: explanted: product type accessory product id a51200 lot# serial# unknown implanted: explanted: product type software product id th90p01 lot# serial# unknown implanted: explanted: product type mobile platform product id wr9220 lot# serial# npp019503n implanted: explanted: product type recharger 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.The patient asked if they could remove the sim card/if the sim card effects being able to access their therapy applications.Patient said they think someone put a cell provider sim card in their device.Patient said their nurse told them they don't need a sim card.Additional information was received from the patient on 2023-mar-14.They reported that someone hacked into their handset by placing a different sim card in it, because the handsets are not supposed to come with a sim card in them.The caller reports that someone had played with their ins and shut it down.The caller also alleged that the handset went dead despite never being used and when they removed it from the case, it was sticky with fingerprints on the back, like someone had been using it with sticky fingers.Reviewed with the caller that we will send a replacement handset and they can send that one back in for analysis.On (b)(6) 2023 the patient called back and was agitated, distraught and their words were, at times, unintelligible.Confirmed their external communicator was detected via bluetooth, not their implant.Pt said their replacement equipment was just delivered but had not yet opened the package.Email sent to replace communicator per patient request.
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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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