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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 Display or Visual Feedback Problem (1184); Migration or Expulsion of Device (1395); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/23/2020
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a consumer and a manufacturer representative regarding a patient with an implantable neurostimulator ( ins). It was reported the patient was having problems with their intellis stimulator. The patient stated a month or two ago they were sent a new controller because their controller was freezing. The patient stated a week later they were then sent a new controller. The patient stated they were now having issues where they would go to adjust their settings and when they tried to decrease their settings and decrease amplitude it would go from 7. 6ma to 3. 4ma. The patient noted other times they would decrease their settings and the settings would increase like normal where it would go up or down by. 1 each time. It was noted it happened once or twice when they turned their implant on and it had happened with each program they had set up. The patient stated they did have adaptive stimulation turned on but each time they noticed it, they had not changed positions. The patient noted they had not had any falls or trauma. The patient was scheduled for an appointment on (b)(6) 2020 to evaluate. No symptoms were reported. No further complications were reported or anticipated.

 
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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 Key10244627
MDR Text Key197988047
Report Number3004209178-2020-11749
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
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,Followup,Followup
Report Date 08/19/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/08/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/14/2019
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 Received08/17/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/20/2018
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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