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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

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MEDTRONIC NEUROMODULATION INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problem Overheating of Device (1437)
Patient Problems Bruise/Contusion (1754); Unspecified Infection (1930); Burning Sensation (2146); Discomfort (2330); Fibrosis (3167)
Event Date 04/01/2021
Event Type  Injury  
Manufacturer Narrative
Report source. Foreign: (b)(6). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (patient, manufacturer representative [rep], healthcare provider [hcp], foreign) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use. It was reported that the rep was with a patient who had discomfort, bruising, and heat within the pocket when stimulation was on and off. This had been occurring for approximately two months. No falls or trauma was reported. No changes in stimulation sensation were reported. The patient reported the issue to the hcp who instructed the patient to ice the area, and to wear loose clothing and a lighter waistband. Last week the patient was told to turn off the stimulator. After turning stimulation off, the pocket appeared to reduce in color from bruising, but the warmth was still present. The ins pocket was assessed and the ins did not move around and appeared to be sitting in the pocket tightly. Pressure applied during recharging did not appear to be the cause, but was discussed. Due to the symptoms still occurring with stimulation off, possible infection, allergy, or twiddler's syndrome were discussed. The hcp did not believe the pocket looked infected or that it appeared like an allergy. The hcp would ask the patient to not recharge for another week then come back to the hcp office to assess the pocket again. At that time they may perform an x-ray.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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 Key12017655
MDR Text Key256752037
Report Number2182207-2021-01066
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/05/2020
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: 06/17/2021 Patient Sequence Number: 1
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