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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC NEUROMODULATION INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Failure to Interrogate (1332); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Communication or Transmission Problem (2896)
Patient Problems Pain (1994); Paralysis (1997); Ambulation Difficulties (2544); Electric Shock (2554)
Event Date 03/11/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id 97745, serial# (b)(4), product type programmer, patient. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported the patient kept receiving no device found on their controller. On (b)(6) 2021 the patient was sitting and on their right leg, on the inside, it felt like they were being electrocuted. The patient could not move, walk, and it was like they were paralyzed and couldn't turn their ins off because the controller kept stating no device found. The patient's friend grabbed their controller and kept trying to turn their ins off, however it took 5-6 tries for the controller to connect with the ins. The patient was going nuts and noted it was like electricity was going through their leg and they could not move their leg. The patient was screaming in pain, they did not know what to do and they felt like they were dying. They were able to turn the ins off and it took a good five minutes to calm down. The patient confirmed they were not covering the top of their controller with their hand, the controller was close to the ins, the controller and ins were both charged when the issue occurred. There was no damage to the pins in the battery compartment and the antenna jack. The patient unlocked their controller and noted that their stimulation was off. The patient was afraid to turn their ins on. The issue was not resolved. A new controller was requested. Considerations for adjusting therapy was reviewed and the patient was redirected to follow up with their healthcare provider.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11496373
MDR Text Key243686354
Report Number2182207-2021-00459
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
Report Date 03/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2019
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 Received03/12/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/30/2018
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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