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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 97725
Device Problem Energy Output Problem (1431)
Patient Problems Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Muscle Weakness (1967); Pain (1994); Sleep Dysfunction (2517); Fluid Discharge (2686); Insufficient Information (4580)
Event Date 03/29/2021
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 trial patient via manufacturer representative who was using an external neurostimulator (ens). It was reported that the patient started their trial last (b)(6), and started to feel new pain on left side in her mid-back as though "someone is punching her in the kidney. " the left-sided mid back/side pain comes and goes, but it was as bad as its been sunday night into monday morning. The patient reported they could not sleep sunday night and woke up in pain, had some issues with her legs being weak, and had 2 episodes of urinary incontinence. The patient reported that this was something that had not occurred since she had been on the trial. It was reported that the manufacturer representative(rep) tried adjusting programming and turned down the intensity. It was reported that when the stimulator was at a lower intensity, the patient felt better. The patient had come into the clinic in a wheelchair because she said her legs were locked up and "not working right" and after being reprogrammed, the patient left walking out of the clinic under her own power. The rep and the patient discussed pulling the leads at that time or finishing the trial and the patient elected to go home and finish the trial.   a healthcare provider noticed some drainage and bleeding on the patients bandage but determined everything was alright. The patient reported they had been getting good therapy relief for her pain during the trial, but the new pain had gotten worse and the patient went to the er on march 29. The patient reported that this new pain got worse or better when stimulation was increased or decreased, respectively so the new pain seemed to be related to stimulation.   it was later reported that the products were explanted march 30; it was determined that the patient was dealing with a possible infection and was admitted to the hospital.

 
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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 Key11596850
MDR Text Key243198802
Report Number2182207-2021-00558
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
PMA/PMN NumberP840001
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 04/28/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/31/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number97725
Device Catalogue Number97725
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 03/31/2021 Patient Sequence Number: 1
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