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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); Unintended Collision (1429); Energy Output Problem (1431); Insufficient Information (3190)
Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Sleep Dysfunction (2517); Cognitive Changes (2551)
Event Date 09/25/2020
Event Type  Injury  
Manufacturer Narrative
Additional information regarding regulatory report # 3004209178-2021-04242 will be submitted as supplementals under this report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A manufacturer representative met with the patient on (b)(6) 2020 to turn on adaptivestim. The patient asked for a couple of new programs to try. The manufacturer representative gave the patient group b and c to try and adaptivestim was activated. At that time, the patient was satisfied with all three groups and denied any other complaints. The manufacturer representative got a call from the patient later that night saying that she could not turn stimulation off. The patient was walked through turning stimulation down. The patient had already had the settings at 0. 0 volts. The patient seemed to be confused and noted that she was still feeling stimulation. The manufacturer representative walked the patient through how to turn stimulation off using the remote. The patient turned stimulation off and acknowledged that the patient programmer was showing that stimulation was off; however, the patient insisted that stimulation was not off and that she could still feel it. The patient was going to try troubleshooting with a family member. On (b)(6) 2020, the patient stated that the stimulation starts okay in the morning, but as the day goes on, it ramps up high and goes on full blast to the point that it is painful. The patient thought that the implantable neurostimulator was causing pain or that the stimulation was too high. The patient mentioned again that her stimulation was still on despite the implantable neurostimulator saying that it was off. The patient verbalized that the patient programmer said stimulation off. The patient met with the manufacturer representative and health care professional on (b)(6) 2020, and it was confirmed that the device was fully functional and there were no issues with the stimulation on or off. The cause of the overstimulation/painful stimulation and the inability to turn stimulation off was unknown. The patient needed re-education in how to work the system. The patient was reprogrammed, and re-educated on how to work the system. The issue was resolved. The patient reported on (b)(6) 2021 that she had a fall at the beginning of (b)(6) 2021, and following the fall, the patient was feeling the stimulation running/surging. The patient noted at that time that the stimulation wouldn't turn off. The patient noted that she was feeling suicidal pain that had been going on over a week. The patient had not slept all night. She was able to turn the implantable neurostimulator down to 0. 0 volts and tried both groups a and b. The patient was finding that the pain is worse with stimulation on. She was in extreme pain and the stimulation was too strong. The patient was advised to turn stimulation down to 0. 0 volts and to keep it off. Pt has been working with healthcare provider (hcp) and an xray was done on (b)(6) 2021 and showed that the ins and leads are all in place. The patient reported that the steps taken to resolve the stimulation issue and pain was that a manufacturer representative reset it, and now it is fine. However, it was also noted as "now big problem. " it was noted that the stimulation issue and pain has been resolved; however, it surges and stops. The patient mentioned that she cannot get it to turn it off on full blast causing terrible pain. The patient noted that the device is faulty and she wishes that she never had it. She mentioned that she needs a new battery.
 
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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 Key11668854
MDR Text Key267159743
Report Number3004209178-2021-06034
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 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2021
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 Received04/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/02/2020
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: 04/14/2021 Patient Sequence Number: 1
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