• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Display or Visual Feedback Problem (1184); Migration or Expulsion of Device (1395); Unexpected Therapeutic Results (1631); Delayed Charge Time (2586); Device Displays Incorrect Message (2591); Battery Problem (2885); Charging Problem (2892); Device Operates Differently Than Expected (2913); Therapeutic or Diagnostic Output Failure (3023); Patient Device Interaction Problem (4001)
Patient Problems Headache (1880); Nausea (1970); Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099); Dizziness (2194); No Known Impact Or Consequence To Patient (2692); Swelling/ Edema (4577)
Event Date 12/23/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer representative regarding the patient. It was reported that while adjusting the programming, the application defaulted to 600 amplitude two or three times. They selected 3. 5 and the double chevron to go to that number rather than waiting or the ramp up, and intellis crashed. There was an error message ¿communication failure. ¿ communication was re-established, and an error message ¿inaccurate data warning¿ was seen. There were no environmental or external factor that should have contributed to the errors. The workflow was restarted as the troubleshooting steps performed, and then the programming could continue. The actions taken to resolve the issue were unknown, but the issue was resolved at the time of the report. The manufacturer representative performed reprogramming and added more energy efficient high dose programming which were non-evolve to address the recharge running out quickly. It was also noted that the recharge connection status that is displayed was showing different between the patient controller and the tablet report. The patient controller was displaying an ¿excellent¿ connection for the duration of charging; however, the tablet report had the session listed as ¿fair¿ on the (b)(4) 2018 report. As of (b)(4) 2018, the swelling and lack of pain relief that the patient was experiencing had not been resolved. The manufacturer representative noted that the high dose programming can take up to 72 hours to wash in. There were no further complications reported.
 
Manufacturer Narrative
Continuation of medical devices: product id a710, product type software. Product id 977c265, serial# (b)(4), implanted: (b)(6) 2017, product type lead. Product id 97745, serial# (b)(4), product type programmer, patient. Product id 97755, serial# (b)(4), product type recharger. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer's representative (rep). It was reported that the patient called the rep following their programming session and stated that they had a terrible response, so much so that they had to turn the stimulation off. The rep had programmed them over the 9/10 disc space and at the bottom of the lead, as the rep hasn't seemed to accomplish any relief so far. The rep used a high density setting of 500/500 and had them evaluate the 2 groups. The patient called on monday and shared his experience, and the rep was going to meet with the patient again on (b)(6) 2018. Following that appointment the patient called and reported headaches when the hd stimulation was on. They go away when stimulation is turned off. The rep saw the patient again and the patient perceived controller issues, but the adaptive stimulation was just shut off. Oor message was discussed. The rep stated that they achieved it while forward bending into the "thinking mans position with elbows on knees from an upright position. The leads had moved one contact spacing since 2 weeks post operation. The rep reported that the patient received 90% pain relief during the t rial. The patient is not getting as good of therapy relief with implant. The patient was programmed with three groups which were created with the patient in the supine position. The patient used hd settings and the caller usually drops them. 5v below sensation and oor level (oor has been occurring. ) on group c the patient was getting "settings not available" at 5. 8ma but caller can get up to 6. 5 ma using the tablet. No other settings were changed. The caller noted that they get the oor message when coming into the tablet if they increase settings too rapidly. The caller also noted being kicked out of programming session if they increase a parameter too rapidly. The controller shows ins at 60% and controller at 30%. On the tablet charge level of ins shows 50%. The patient uses the following electrodes and settings: (b)(6) -11, b: 1-(b)(6), 6. 5ma c: (b)(6). Imped indicate: (b)(6)
=
920 ohms; (b)(6)
=
880 2/11
=
940. During programming session the tablet showed oor in program 1 of group c, when patient leaned forward. The caller noted that the x-ray showed lead moved slightly. The caller was thinking about using 0-1 electrodes. It was reviewed that increasing pulse width over 120 microseconds can help work around oor issues. When the patient was using 500us 500hz for programming it was noted that they had headaches and nausea that occurred with stimulation on and resolved when turned off. On (b)(6) while patient was sitting during programming session the patient noted getting some therapy relief in their feet. Patient also reported lightheadedness on (b)(6) using group b. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacture representative (rep) on 2018-mar-21. The rep stated that the patient called them on (b)(6) 2018 and stated that the first part of the week was good but now they are back to little to no relief. They texted the healthcare professional (hcp) and requested an x-ray and to see them on (b)(6) 2018 at 2:30pm. The rep stated that no actions were taken to resolve the lead migration, headaches, oor messages, and lack of relief. They reprogrammed the patient. The cause of the lead migration was unknown but it seemed to happen between the implant and post-operatively visit. The lead migration was not resolved, the headaches, nausea, and oor messages were resolved, but the lack of relief was not resolved. This information was confirmed with the physician. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the rep reported that they were texted by the patient and told that all 3 of the groups that were programmed since last they met were evaluated and none of them provided any relief. No further complications were reported.
 
Manufacturer Narrative
Product type software product id 977c265 lot# (b)(4) implanted: (b)(6)2017 explanted: product type lead product id 97745 lot# (b)(4) implanted: explanted: product type programmer, patient product id 97755 lot# (b)(4) implanted: explanted: product type recharger if information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer representative on 04/30/2018. It was reported that patient had good coverage during the trial, but since implant has not had good coverage. An xray showed that the lead had moved down so the patient had been reprogrammed and still does not get good coverage. No further complications were reported.
 
Manufacturer Narrative
Other applicable components are: product id: 97745, serial# (b)(4), product type: programmer. Patient product id: 97755, serial# (b)(4), product type: recharger. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacture representative (rep) via a patient with an implantable neurostimulator (ins) for spinal pain and complex regular pain syndrome type i. Recharging seems to be more cumbersome and take longer. It is more finicky and runs out sooner. The pain seems to be worse now than before being implanted. The patient feels left calf to foot swelling. The rep visualized and took a picture. The patient is not getting any relief and they have tried three times to program and get return or pain relief that the patient did during the trial. There were no known causes. The rep would send in the patient diaries. Actions taken to resolve the issue include doing the initial programming, meeting 2 weeks post-operatively and reprogramming two times after that. The rep is meeting the patient on the day of the report. As of yesterday the patient had to charge twice as the battery seems to discharge quicker. The issue has not yet been resolved but the patient was noted to be alive with no injury. No further complications were reported/are anticipated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7237568
MDR Text Key103562731
Report Number3004209178-2018-01956
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2018
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-