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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 97725
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Malaise (2359)
Event Date 06/01/2021
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 was hospitalized because she felt sick. Patient was drinking pedialyte with antibiotics. Patient was told to turn stimulator off to see if that was making her sick, 4 hours before she went to the hospital. Patient stated she still felt sick so she was told to go to the hospital. Patient is being treated in the hospital. The provider was notified. Issue resolved at this time.

 
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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 Key11929970
MDR Text Key254039777
Report Number2182207-2021-00963
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 06/04/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/03/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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 Received06/03/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/25/2021
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: 06/03/2021 Patient Sequence Number: 1
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