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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); Unintended Collision (1429); Insufficient Information (3190); Data Problem (3196)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)
Event Date 07/16/2020
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 who was implanted with an implantable neurostimulator (ins). It was reported that around (b)(6) 2020, the patient stopped feeling the stimulation and their legs were hurting. They explained that normally, when they would clear their throat or sit on a piece of furniture, they could feel the stimulation and that's what told them the device was working. The patient checked their controller and found that all of their settings were down to "0" even though they hadn't changed anything. They were able to get the settings back to normal and had remained resolved. On july 17th, they noticed that the ins wasn't depleting like it normally does. One day the ins charge was at 80% and then another day it was at 90%. They then changed their settings to 9. 9 to see if they could feel stimulation, but they couldn't feel anything. The patient confirmed they had fallen before this event began and again after july 16th. It was explained that their balance was not good. During the call, the patient checked the ins charge and reported that it decreased 10% since the night prior. The patient was redirected to see their doctor to check the device since it may have been affected by the first fall.

 
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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 Key10311098
MDR Text Key199983953
Report Number3004209178-2020-12659
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,Followup
Report Date 08/19/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/28/2019
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 Received08/12/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/01/2018
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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