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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 Insufficient Information (3190); Data Problem (3196)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 05/28/2020
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 regarding a patient with an implantable neurostimulator (ins). It was reported the patient was currently on group b with program 1 around 3. 8/3. 9ma and program 2 at 3. 1ma. The patient stated they didn't press any buttons but they noticed that both programs were set to 0. 0. The patient stated they had maintained the battery charge for the ins, noted it was 70% that morning, and was able to increase stimulation. The patient inquired what would cause the stimulation to go to 0. 0. The patient confirmed they were reprogrammed and was programmed with adaptive stim on their settings. The patient stated ever since programming they had noticed therapy relief to a degree but indicated they did not like adaptive stim. It was reviewed the likelihood the stimulation changed due to adaptive stim. The patient went in to each program and confirmed each program was on, program 1 was set to 3. 8ma, program 2 was set to 3. 1ma, and that adaptive stim was turned off for both programs. Screen use was reviewed and the patient locked and unlocked the controller and double checked the settings. The patient was encouraged to follow up with their healthcare provider if they continued to have concerns regarding adaptive stim. 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 Key10145872
MDR Text Key194973133
Report Number3004209178-2020-10191
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 CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 06/11/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/28/2019
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 Received06/10/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/13/2018
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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