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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

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problems Failure to Interrogate (1332); Charging Problem (2892); Communication or Transmission Problem (2896)
Patient Problems Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908)
Event Date 06/30/2021
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 patient who was implanted with an implantable neurostimulator (ins) for cervical radiculopathy,033:n on-malignant pain it was reported that patient reported they are not able to charge the implant, getting no device found, try again screen when charging the implant. Patient services (ps) asked patient to inspect the recharger (rtm) for damage and patient and her husband (bobby) said they see discoloration and black is separated on the paddle and cord connection. The issue was not resolved. An email was sent to the repair department to replace the device. Patient called back from to say that she received replacement rtm but she still wasn't able to charge. Patient had connected replacement rtm, attempted to start charging session got the "no device found" message, clicked recharge and got to the 'trying to recharge" screen with numbers on it. Patient said she did this for about 10 minutes and then the controller told her that controller itself needed to be charged. Patient services (pss) had patient look at controller port and pins inside port looked fine, controller was charging like normal from wall and was showing 'no device found' when patient tried to connect wirelessly. Pss recommended patient charge controller up sufficiently and then attempt a passive recharge mode session. They later called back and reported that because of not being able to charge, they were without therapy. Patient said without pain relief their blood pressure went up and caused their macula to bleed. Patient met with medtronic representative today and rep attempted to go through passive recharge mode for an hour without success. Pss attempted to go through troubleshooting with patient and had patient reset controller and try to start implant charging session, patient made it to the 'trying to recharge' screen and all three numbers on the screen were 99, implant still wouldn't charge. A replacement controller and battery pack were sent out. Additional information was received from the manufacturer representative (rep). It was reported the patient is still unable to recharge implant after receiving new patient programmer and charging cord. The issue has not been resolved.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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 Key12142320
MDR Text Key260699826
Report Number3004209178-2021-10584
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,Followup
Report Date 09/15/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/09/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/28/2020
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/11/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/28/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/09/2021 Patient Sequence Number: 1
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