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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Impedance Problem (2950); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Pain (1994); Dizziness (2194); Inadequate Pain Relief (2388)
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a consumer via manufacturer representative (rep) with implantable neurostimulator (ins) for unknown indication. It was reported the programmer was reading settings not available. Impedances were well within limits, yet the system was still showing out of range (oor). The rep spent quite a bit of time trying to program around the issues with limited success. When the rep met with the patient, he said he could not feel the stimulation and was seeing ¿not able to deliver desired settings on his programmer. ¿ an impedance test returned normal results. The rep reprogrammed and increased rate, which enabled the patient to feel the stimulation. He was still seeing the not able to deliver desired settings at low amplitude message. The rep thinks it is the limitations of the system to his oors at low impedances and strengths for whatever reason. It was unknown whether the issue was resolved. No further complications were reported/anticipated. Additional information was received from the manufacturer representative (rep) 2019-10-25. It was reported the manufacturer representative (rep) met with the patient for reprogramming. The patient was not getting much pa in relief. They spent quite a bit of time reprogramming and unfortunately the patient hits oor when he¿s barely feeling stimulation. He runs into oor no matter how he is programmed, whether rep changed pulse width, rate, or electron configuration, it doesn't seem to matter. The manufacturer representative (rep) provided him with three new groups to try. Additional information was received from a manufacturer¿s representative (rep). The rep reported that the patient was having the same problem not able to deliver desired settings with his programmer. The rep also reported that the system was shutting off every 15 minutes or so. The rep suspected this had something to do with the oor problem and he was just confused. Additional information was received from a manufacturer¿s representative (rep). The rep reported that they weren't sure why the patient was seeing the settings not available message since impedances were well within range. The rep reprogrammed the patient to improve the strength of stimulation, but they were still getting oor at fairly low amplitudes. Additional information received from the manufacturer representative reported that there wasn't anything in the diary logs that indicated the system was turned off every 15 minutes. The patient had been reprogrammed to improve the strength of stimulation. It was stated that the issue was not resolved due to the limitations of the system as the message would be seen if the patient turned it up beyond the capabilities of the system. Additional information was received from the patient. Patient stated he was "having increased trouble trying to recharge the ins". He mentioned while charging he could get excellent coupling before "it drops out". Patient stated "it either goes to select recharge again or something. He said it almost seems like the unit is floating around in different spots". Pt confirmed he doesn't think ins was moving in body, but stated he have a hard time keeping connection when recharger antenna (rtm) was held in one spot on body. He tried to charge for 3 hours today before he finally gave up after getting "software error". Patient also mentioned he gets "quite a bit of termination" stating "i'll start hurting after it's charged and it's like it's reached its impedance and the ins would turn off". Patient stated this had occurred since implant. Patient stated "i know if the settings are too high, it may terminate in 10 minutes". Patient was asked to clarify terminate and he stated what h e meant by "terminated" was that it was the exact message that comes up on his screen. Additional information was received from the patient. It was reported that he had a problem develop with the rtm as it took like four hours to get the ins fully charged up when it only takes an hour when the controller says the connection is between 80-90. On (b)(6) the ins got up to 96% while the ins was recharging and that the controller then said the ins was fully charged to 100%. He went on stating that he was 95% pain free during the trial period and that he went off of all pain pills. He wanted to test the trial ins so he went out and tilled the flower garden, but that he had to kick up the stimulation intensity about three points until it put him right back to being 95% pain free. With the permanent implant, he's lucky to get 50% pain relief. T he's been told by reps that 50% pain relief is good, however he doesn't consider 50% pain relief good so he hasn't been happy with the permanent ins as he was spoiled with the trial ins. Information was received from a patient (pt) regarding an implantable neurostimulator (ins). The reason for call was the pt noticed his stimulator was not doing anything. It wasn't working, and the pt checked and noticed an error. It was clarified that stimulation had shut off because of impedances (pt said that is what he was told. ) he was told there was an impedance caused by fluid or something. Pt said it booted and it came back on. Pt said he was dizzy. Pt also provided information about meeting with the reps for programming. If it isn't doing enough, he kicks it up and the rep will increase to where it 'bites' quite a bit, then will knock it down. The patient was redirected to their healthcare provider and the rep to further address the issue.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11307269
MDR Text Key231140905
Report Number3004209178-2021-02309
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/10/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/28/2019
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/28/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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