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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 Failure to Deliver Energy (1211); Data Problem (3196)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

The consumer reported via the manufacturer representative that the stimulation turns off automatically. There were no known external or patient factors that may have contributed to the issue. The patient stated she never turns stimulation off and when she notices that she no longer fells stimulation she synced to the controller and it indicated the stimulation had turned off. The patient was directed to monitor when stimulation turns off and the issue was not resolved at the time of the report. Additional information was received from the rep on june 19, 2020. They confirmed that they had discussed the following information with the physician. It was reported that the cause of the stimulation turning off was not yet determined. They confirmed that the patient did not have any adaptive stimulation settings enabled or other programming that would have led to the stimulation turning off. The patient was to ld to continue to monitor when the stimulation was turning off and to check with the controller to confirm that it says the ins was off. The issue has not yet been resolved; no additional actions or interventions have been planned to resolve this event. 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 Key10186975
MDR Text Key196243946
Report Number3004209178-2020-10885
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
Report Date 07/22/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/14/2020
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 Received07/17/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/23/2019
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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