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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 Failure to Charge (1085); Failure to Deliver Energy (1211); Failure to Interrogate (1332); Overheating of Device (1437); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)
Patient Problems Fatigue (1849); Headache (1880); Nausea (1970); Pain (1994); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331); Malaise (2359); Loss of consciousness (2418); Ambulation Difficulties (2544); Alteration In Body Temperature (2682)
Event Date 03/01/2019
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 consumer regarding a patient who is implanted with a neurostimulator for non-malignant pain. It was reported that the patient¿s device has not been working for some time. The implantable neurostimulator was not charging, and the patient controller constantly gives her an error message that she is not charging and tells her it cannot find the device and to put it closer to her body. The patient has not charged in a week, but the patient also noted that she has not been able to charge the implantable neurostimulator for almost two weeks. The patient has put the device over her implantable neurostimulator, and it is still not finding the device. While speaking with a patient service specialist, the patient used the patient controller. The patient controller was showing no device found. Instead of pressing try again, the patient pressed recharge, and then the patient controller showed screen 86 cannot recharge. Patient controller battery is too low. The patient plugged the patient controller into the wall and it was showing green and looked like it was charging. After charging up the patient controller, it was still not connecting to the implantable neurostimulator. During troubleshooting, the patient was still seeing the no device found screen, so the patient started a passive recharge mode. The patient was able to connect and saw the green light blinking. After charging up the patient controller, it was still not connecting to the implantable neurostimulator. During troubleshooting, the patient was still seeing the no device found screen, so the patient started a passive recharge mode. The patient was able to connect and saw the green light blinking. Additionally, it was reported that the patient¿s device will work for maybe a day or two, and then it will not work again. Starting in 2019 (for approximately two months), most of the days, the patient is not able to get out of her bed. Like on the day of the report, she felt very drained, with no energy, and like she is unable to do anything as it hurts her to go to work like this. The patient also reports feeling nausea. When the patient is not able to charge up, the patient¿s body feels a hot sensation around the implantable neurostimulator area. The patient is not able to get out of bed because she has no energy to get out of bed until she actually charges. It bothers the patient¿s feet. The patient would like to charge her implantable neurostimulator right now for the energy because her whole body is drained. She can feel herself ¿beeping¿ which was clarified to mean that the patient is feeling stimulation inside of her body. The patient was in the hospital because she was blanked out on (b)(6) 2019 and found unresponsive. It was noted that they had tried to help the patient but could not because of the implant. Additionally, the patient noted that this is giving her headaches. All of these issues started in 2019, about two months prior to the report. There were no further complications reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the patient. It was reported that the patient couldn't charge successfully and it kept saying "cannot find the device". They removed the battery pack and put it back in and when they placed the antenna over the ins it said "cannot find device" and the controller was at 80%. Touching "try again" caused the controller to look for the device but after several attempts of repositioning the antenna the patient was unsuccessful. The ins was low and the icon was red. Stimulation stopped yesterday and since then they had been feeling nauseated and not well- they felt weak. Whenever the ins wasn't charged they felt weak. The patient mentioned something about how when they first got the ins they could feel the difference when the ins was charged and when it wasn't charged- if it was charged they had lots of energy and if it wasn't they felt very different; they felt nauseous and their eyes hurt. No further complications reported.
 
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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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8654717
MDR Text Key146522669
Report Number3004209178-2019-10546
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2018
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 Received06/04/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/30/2019 Patient Sequence Number: 1
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