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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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| Model Number 97715 |
| Device Problems
Failure to Deliver Energy (1211); Failure to Interrogate (1332); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)
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| Patient Problem
Pain (1994)
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| Event Date 02/06/2024 |
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Event Type
malfunction
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Manufacturer Narrative
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Continuation of d10: product id 97745 lot# serial# (b)(6), product type programmer, patient product id m995402a001 , product type product id 97755 lot# serial# (b)(6), product type recharger product id 97745 lot# serial# (b)(6), product type programmer, patient product id m943899a , product type accessory product id 97755 lot# serial# (b)(6),product type recharger product id 97745 lot# serial# (b)(6), product type programmer, patient medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Information was received from a patient (pt) regarding an external device. it was reported that the pt could not get their equipment to start up and it had been going on for over a week now.Every time hit button to do anything they got position the recharger over the implant and hit continue when the rtm was plugged into the controller.Pt then said the ins battery was completely was run down for they got no device found and they could not recharge it.They could play with it to get it charged and now it would not do nothing.They had not found it for over a week now and they had no stimulation and their back and they were hurting bad.Pt then clarified event date stating it had been acting up about for about a month ago then a week ago they could not recharge the ins all the way.Pt noted when the unit was working it would take them 2 hours to charge but today they would not know since it was down all the way.During call pt verified no damage to the rtm or to the controller charging port.Pt reset the controller and blew into the controller charging port.Pt attempted to recharge the ins and was getting no device found.Pt said they knew the controller had a full charge for it was charged last night.Pt attempted to go through passive recharge mode and they got unable to recharge (screen 74).The issue was not resolved.An email was sent to the repair department to replace the controller.See case # (b)(4).For the report of this was a new cord and paddle; when they shipped out the new paddle the mail lady found that a few days later on the ground about 5 mailboxes away.An email was also sent to registration to update address.Additional information received.Case re-opened and re-assigned to send an email to repair for a replacement recharger.Patient called in sharing they got the replacement controller and went through the pairing process but could not advance past the screen "connect, connect the recharger (13)".Patient confirmed that their controller was at 100%.Agent reviewed information with the patient.Agent emailed repair to replace the recharger.Upon further review, agent would like to add that they confirmed that the patient was in fact trying to connect the recharger but it was as if the controller wasn't recognizing that the recharger cord was connected to it.Patient also confirmed that there was no issue with the controller when the ac power cord was connected to it.(b)(6) 2024, (b)(4)., rpl 421812, 422373, 422375, 423016 (con, rep): additional information was received from the patient.Patient called back and stated they received the replacement controller and recharger but patient still couldn't turn up their stimulation.Patient inquired on how they could get ahold of a medtronic representative.Agent reviewed information and redirected patient to their hcp to address the issue.Agent provided nas phone number.Pt called in and reported they had met with their mdt representative and tried trouble shooting for 2 hours but were unable to get the issue resolved.They attempted to go through passive recharge mode, but could not advance past.Pt could not get the controller to find the device without the recharger.During the call pt was still unable to advance past passive recharge mode.An email was sent to repair to replace the controller.Patient called stated they received the controller and they to make sure the controller is paired up to the ins.Patient started charging the ins and getting the passive recharge screen with all high numbers.Agent recommend patient continue to charge the ins until the ins gets to normal recharging screen.Agent will patient back to confirm they are able to charge the ins.Patient mentioned they increase the stimulation when they go to shower because their back hurts when they take a shower.Agent called back to patient to confirm they are able to charge the ins normally and out of passive recharge mode.The call went to voicemail and agent left message for patient to call for assistance if necessary.Pt called back in and reported they are still unable to advance past passive recharge mode.Pt was using the replacement controller and recharger.Agent messaged to the repair team and they suggested agent replace both pieces of equipment as the patient has already had equipment replaced and also they have met with their mdt representative.Agent sent an email to repair requesting a new controller and recharger.Pt offered that they will meet with their representative again so the rep can walk them through recharging the ins.Patient called back and stated they received the replacement controller/recharger and patient got a software issue that didn't have other details and the controller also went black and unresponsive when charging the implant.During the call patient removed the battery and plugged the ac power.Controller powered on and patient got the hello screen.Patient selected implant.Patient inserted the battery and green light was flashing.Patient plugged the recharger and selected the implant serial number.Patient kept getting no device found.Patient got 99/99/99 on the passive recharge mode screen then 99/99/100.Agent will call patient back to check on passive recharge mode status.Upon further review patient also cleaned the recharger pin sand blew air into the controller charging port.Patient attempted to make an outbound call but was sent straight to voicemail.Agent left 2 voicemails.Patient noted previously they were expecting a call back from a previous agent; agent suspected patient didn't check their voicemail.Pt called back stating that they didn't get a call back from the previous agent.The equipment was stuck in passive recharge mode.Agent had the pt disconnect the recharger from the controller and then reset the controller.Pt had gotten the controller to start setting up in clinician mode (pt saw screen 67 clinicians only), so agent had the pt go back and start setting up the controller for implant.After connecting the recharger, pt saw no device found, so agent had the pt tap recharge to go through passive recharge mode again.Pt confirmed seeing the controller light flashing green.Pt saw the three numbers as 98 98 98 on the trying to recharge screen.Agent advised the pt to remain in passive recharge mode and that agent would call them back in about 20 minutes to check the status.Agent called the pt back as previously promised, however the call went straight to pt's voicemail.Agent left a message for the pt advising pt to call ps back if further assistance was needed.Patient called back and stated they have been in passive recharge since this morning and unable to advance passive recharge mode to charge their implant in a normal state.Patient mentioned their back was hurting real bad.Agent directed patient to follow up with their hcp.The rep also reported the belt was broken and noted they met with this patient at his last appointment.He was having difficulty charging.He has lost significant amount of weight.His re-charging cable/antenna was loose when connected to the patient programmer.Additional information was received from a manufacturer representative (rep).The rep called while with the patient.Patient is still seeing no device found.Had caller try aa batteries and was able to connect to the ins, on and off, up and down.Tried battery pack again and showed pack is at 60% but not able to connect to ins, no device found.Battery pack/area does not look corroded.Battery pack fits in snug.Caller had reported she had removed and reseated battery pack several times before.Passive recharging showed but no regular recharging.Will request replacement of battery pack.2024-mar-19 additional information was received from the patient via manufacturer representative.It was reported that they sent him out a new patient programmer and charging cable.Patient continues to have issues with patient programmer charging his internal neurostimulator.Today cs was able to interrogate battery with her tablet however, patient was unable to connect to battery and recharge with patient programmer.Patient states when he gets home from taking his wife to her doctors appointment.He will call medtronic back and speak to them about sending out a new patient programmer and charging cable.Patient states he has lost weight and is using his wife¿s non medtronic belt to help hold recharger in place as it puts more pressure on the ins and recharger to hold it in place.Cs was able to connect a patient battery using tablet.However patient was having issues when using programmer and recharger.Patient programmer states it cannot find battery.Patient states he¿s already called medtronic patient services once, but will call later (b)(6) or (b)(6)after taking his wife to her doctors appointment.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Additional information was received from a manufacturer representative (rep).The rep reported that it is unknown if the issue is resolved as the manufacturer was supposed to send patient a programmer battery.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Additional information received from a manufacturer representative.It was reported that the patient was sent a replacement controller battery pack to try and resolve their charging issue.It was unknown if the issue was resolved.The patient reported they would contact the manufacturer or their physician's office if they had any further issues after receiving their battery replacement.
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Search Alerts/Recalls
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