|
MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
|
Back to Search Results |
|
| Model Number 97715 |
| Device Problems
Unintended Collision (1429); Energy Output Problem (1431); Overheating of Device (1437); Delayed Charge Time (2586); Insufficient Information (3190)
|
| Patient Problems
Burn(s) (1757); Dyspnea (1816); Fall (1848); Hemorrhage/Bleeding (1888); Device Overstimulation of Tissue (1991); Paralysis (1997); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
| Event Date 03/07/2022 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
If information is provided in the future, a supplemental report will be issued.
|
| |
|
Event Description
|
|
Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt reported they have had 3 incidents/injuries recently.Pt stated they were injured mowing the lawn and then slipped and fell in the bathtub twice.Pt also commented that their ins became hot today.Patient was redirected to their health care professional.
|
| |
|
Manufacturer Narrative
|
|
Continuation of d10: product id 97745 lot# serial# unknown implanted: explanted: product type programmer, patient 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.
|
| |
|
Event Description
|
|
The reason for call was that they told the rep that there might be a problem with the battery as it wasn't charging.Pt stated that they put the charger cord on it and it chargedup to 100% like it was supposed to; pss understood that the controller charged fully from the power supply.Pt stated that they would start charging the ins and that excellent was showing but there was a red triangle (next to the ins battery) that would usually start turning green after a half hour and then everything would go perfect.Pt stated that the controller battery would start dropping from 100% to 90% to 30%.Pt stated that the rep was not willing to work with them.Pt confirmed that their issue was that it was taking a long time for the ins to recharge.Pt stated that they had a fall awhile back and that they couldn't give up the external equipment until they had an investigation done to figure out what caused them to fall and have their neck damaged.Pt stated that the reps/hcps were trying to cover their butts since they may have screwed up and "overheated" and "over-programmed" them.Pt stated that when they were trying to charge up (the ins) one of the cords was damaged and overheated the battery and shorted them out and burnt their butt.Pss attempted to address the issue with the cord; pt stated that they had the cord and that they weren't giving it up and they were going to have an investigation done to prove their point so no one could cover their butts.Pss redirected pt to hcp to have the ins checked.Pt stated that they were in the shower a couple days ago and they fell twice and hit their neck so they were now having paralysis.Pt stated that hcp and reps were trying to brush them off and leave them for dead basically.Pt stated that they wanted the whole wiring system out of them and have everything brand new put in as there was always something.Pt stated that one day the controller went dead and that they were told that maybe the battery was just dead; pt stated no and that when they were in the moon's shadow and all of the electronics shut down that that wasn't supposed to happen.Pt stated that they were supposed to go to the hospital last night.Pt wanted to know what hcp and reps did wrong.Pt stated that when they first got the ins it was great and then the rep started doing crazy programming to where they could feel the stimulation and they guessed it was a little too high as they started falling.Pss kept urging the pt throughout the call to schedule an appt with a physician to have the ins checked.Pt stated that hcp wouldn't talk about the issues.Pss offered to e-mail the pt a physician locator listing, however pt declined and stated that if they (hcp/reps) made a problem for them (pt) then they (hcp/reps) would have to take it out of their (hcp/reps) paychecks and they (pt) weren't playing games with anyone.Pt sated that they were on a mayday and that no one was listening to them and they were just told to call ps.Pt stated that they would find someone and have all of the electronics and components checked so they could find out the truth.Pt then asked for pss to send them a hcp listing.Pss asked the pt for the rep's name, however pt would not provide.Pss asked the pt when the rep was first made aware of the issues and pt stated that it had been almost a year ago when all of this started and that it was probably in january or december.Pt provided dr.Heres as their managing hcp.Pt stated that dr.Bailey implanted the ins but that hcp was a coward and just wanted their vacation.Pt stated that hcp did this to them every summer.Pt stated that they had a lot going on in their body and that they should b e dead by now.Pt stated that having paralysis was dangerous as they could be driving and wouldn't know where they were at all of a sudden and that they would be stuck in a time zone and by the time they woke up they lost track of time and was hard to breathe.Pt stated that others thought that they were sleeping or dozing off for a little bit.Pt stated that it "sucks the hell" out of them and that last night it was attacking them left and right.Pt stated that they went through sleep apnea and brain scans and the whole works.Pt kept blaming the reps and hcps for the issues during the call and stating that they (reps/hcps) wouldn't be getting a paycheck.Pt was difficult for pss to understand and follow clearly during the call.Pt stated that they were getting banged up as friday they were mowing the lawn and fell down and got ripped up on the side of their ribs which almost punched a whole and they almost died.Pt stated that the rep didn't want to hear about their problems and that the rep would only program the ins.Pt stated that the wire wasn't charging now and that it wasn't the charger since the charger was giving juice to the stimulator which was carrying a 100% charge (pss understood that the pt was referring to the ins not charging and that the controller fully charged from the power supply).Pt stated that when they put it in them it would give a red beep, then a yellow beep, then it started giving them a green beep which would mean that it was working (pss understood that the pt was then referring to recharge the ins).Pt stated that it would say excellent then good and it would charge, however now it was not charging the ins like it was supposed to.Pt then started describing the recharger cord again and pt stated that sometimes it was showing 80% or 90%.Pt stated that they didn't know why it wasn't turning on so they reset the controller as it had been off for awhile but they always kept it charged.Pt stated that they turned the ins off and then turned the ins back on.Pt stated that they were told on their (hcp/reps) part, they were going to shut the device off to give them a vacation as the pt had all of their teeth pulled.Pt stated that the rep wanted them to charge the ins today for a couple hours.Pt stated that the number on top (controller battery) was dropping and on the bottom (ins battery) it should have lit up green and showed ~% or 40% or 30%.Pt stated that they had done it before (recharged the ins) hundreds of time and they never had a problem.Pt stated that the problems started when they fell.Pt stated that the components just went dead one day and didn't want to come back on and that wasn't supposed to happen unless there was a problem.Pt stated that they had to wait ten minutes, then twenty minutes, then thirty minutes, and then they had to reset the controller several times and then the device started to work.Pt noted that they have an appt on the 28th.Pt stated that they were awake and felt everything during the implanting procedure.Pt stated that they had been working hard without the stimulator and that they had been calling but no one returns their calls.Pt stated that they really hurt themselves from everything they had been doing and that they were having a problem with paralysis.
|
| |
|
Manufacturer Narrative
|
|
Continuation of d10: product id 97745; serial# unknown; product type programmer, patient.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.
|
| |
|
Event Description
|
|
Patient called back and repeated much of the same information below.Patient was difficult to understand and follow as they would keep changing the subject.Patient stated that everything was working today and they got the implant charged to 100%.Patient stated that the issue is that the controller keeps showing a triangle with an exclamation mark and someone at dr.Heres's office said that means there's a malfunction.Patient repeated that they had a fall in the bathtub and hit their neck on the side of the tub and now they think the wiring or battery in their body is broken.Patient stated that the lady who controls the stimulation is trying to cover her tracks because she changed the stimulation settings and that caused their fall in the bathtub.Patient stated that they just want to get an mri to have the implanted system checked, but the "lady" kept saying they can't do that and told patient to call medtronic.Patient stated they are in a lot of pain and their body is hanging on by a thread.Patient noted that their back sometimes spazzes so bad and then they start bleeding and their doctor said it was maybe hemorrhoids but patient thinks it's the implanted system.Patient mentioned getting a steroid shot in their neck.Patient repeated about the wire that was making their butt burn and noted that they're going to return the replaced equipment after they find someone to look at it because they need proof that they're not crazy.Patient continued to repeat a lot of previously documented information including the paralysis as well as discussed unrelated topics like local violent crimes.Patient eventually stated they would call back if the device stopped working again and was going to try and continue to reach out to dr.Heres's office to get an mri.Agent documented reported information.Pt stated they needed to have an mri to figure out if there were issues with the wires because they fell 3 times and pt noted they hit their neck on a cast iron tub twice.Pt stated they started having problems with paralysis and that the pt was not getting enough oxygen to the brain and they thought the stimulator was causing it (ps understood this as pt was in contact with their hcps dr.Harris and dr.Bailey).Pt noted the wire that that went to the battery heated up (ps understood this as the recharger cord).Pt noted they fell on the side of a pole and ripped the side of their lungs.Pt felt that their doctors and representatives abandoned them and that they were hiding from the pt.Pt noted pt's hcp had to approve them to get an mri and pt noted their hcp put needles in them.Pt noted there were so many things wrong with them.Ps had difficulty hearing and following pt during the call.Because of pt's experience with their hcps and representatives ps offered to send a copy of physician listings to the pt so that the pt could connect with another hcp.Pt requested a physical copy.
|
| |
|
Search Alerts/Recalls
|
|
|
