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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 Migration or Expulsion of Device (1395); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517); Electric Shock (2554)
Event Date 03/10/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from the patient regarding their implantable neurostimulator (ins). It was reported that patient is having therapy concerns. Patient clarified that her ins has not resolved the pain in her lower back and she is having excruciating pain in her lower back that had gotten worse. A manufacturer representative informed the patient that this is due to patient's bone or muscle, but patient stated she does not think this is correct and added that ins has only helped with her walking, it should also be helping with her lower back pain. This had been going on since the date of implant. Patient has had reprogramming due to this issue twice and stated it is still not resolved. When she had reprogramming her hernia kept giving hot shots - she had to turn off stimulation due to this. Patient also reported that she can't sleep at night because she feels electrical shocks from her ins; can't do any house work due to this issue. Patient turns stimulation off when she feels the shocking sensation and stated that she no longer feels the shocking, but stated she still feels a little trickle. Patient further clarified it feel like taking hands on a keyboard, light little shocks. Patient denied any trauma/falls and stated she had x-rays done due to this issue and was told the leads are placed where they should be. Patient was redirected to their hcp. No further complications were reported. Additional information was received from the rep. It was reported that patient was disgusted with whole procedure which was supposed to take care of back and hip pain. Patient's hip is fine (every once in a while she gets little twinges) but now her back has more pain than she ever had in her life that goes from her back up all the way up between her shoulder blades. Patient stated rep says stimulation does not penetrate muscle and bone. Last month she told her hcp she wants the thing out of her she is not getting any satisfaction. The rep had the stimulator blasting so bad patient jumped out of her chair from the pain that went through this thing. Not only did the rep do it once she did it a couple more times, so finally she lowered the voltage. Pt said she has a hernia in her right, lower front, which she has had since prior to getting the stimulator. Patient said her implant is upper buttock on the right side. Patient described her pain saying she is good till 3 (pm) after that cannot move the pain is excruciating and medications don't' touch it she has tried oxycodone, hydrocodone. Pt said she needs help from the beginning of the day just getting out of bed is a miracle. Pt said the spinal cord stimulation (scs) takes care of the pain in her hip. Pt said prior to scs she had been unable to walk because the pain was so excruciating in her leg, prior to stimulator she could not walk and she is now able to walk. Pt said, even when stim is off she feels stim on the right side not over the leg, when it is totally off it is like someone is playing the piano up and down the keys this has been a living hell if she has to take it out she does not care anymore. Pt said her hcp told her everything is correct and they did an x-ray that confirmed everything was implanted where it was supposed to be. Pt said she told them she would give it 6 months, in 2 more months if things don't get better she wants it out, she will walk with crutches, a walker the pain is that bad she cannot handle it. Pt said she does not drink the only thing that kills the pain is a big glass of wine then she is goofy the rest of the night, she's going to be an alcoholic before this is done. Patient was redirected to their hcp. No further complications were reported. Additional information was received from the rep. It was reported that rep last saw the patient on (b)(6) 2020. The patient told them about a "shocking" sensation at night when she laid down in bed. Rep asked the patient if she had turned the stimulator down when she laid down, she reported she had not. Rep offered to activate the patient's sensor, but the patient refused. Rep encouraged the patient that she needed to turn her stimulator down when she laid down. At the end of the appointment, rep told the patient to turn the stimulator down when she went to bed and call them with any questions. Rep ensured the patient felt comfortable with using the remote. When the patient was trying to light the screen up with the remote unlocked, rep noticed that the patient would hold down the up arrow and increase the stimulator without realizing it. Rep educated the patient on remote use and concluded that this "shocking" sensation could be user error and not a device issue. Rep has not heard from the patient since so they assumed that the problem had resolved. Rep stated that they did not blast her with the stimulator. The patient is very sensitive and rep would slowly increase the stimulator with one click every few seconds. Rep would never want to intentionally cause discomfort to a patient by blasting them with stimulation. The patient gets some sensation at the site of her hernia because the leads have slightly migrated since implant; which both the patient and physician are aware of. Rep tried to help this patient multiple times. The specific issue of "shocks" appeared to be a user error when the rep last saw the patient and not a device issue. The cause of therapy/device not working for back pain was not determined. The doctor has encouraged the patient to go to physical therapy because the md believes it is a muscle weakness issue and not a stimulator issue. The patient refuses to go to physical therapy. The patient was very irritated when on (b)(6) 2020 and walked out on the doctor because she had a disagreement with the doctor's np.  patient's weight was unknown. No further complications were reported.
 
Manufacturer Narrative
Correction - added. Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2020, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2020, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
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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 Key10212264
MDR Text Key196996194
Report Number3004209178-2020-11317
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
Report Date 06/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2021
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 Received06/29/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/02/2020
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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