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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 Communication or Transmission Problem (2896); Data Problem (3196)
Patient Problem Pain (1994)
Event Date 01/01/2020
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 97745, serial#: (b)(4), product type: programmer, patient. Product id: 97755, serial#: (b)(4), product type: recharger. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a manufacturer rep regarding a patient with an implantable neurostimulator (ins). The rep reported the patient stated that the controller was causing problems, it will suddenly go out of whack, what he has it set on shoots as high as it can go and sends the pain into his brain. It was reported that the patient clarified that they were not having a shock and didn't mean a shock. It was reported that when the patient is trying to recharge the ins, the controller shuts down, it disconnects often, if he moves a little bit it disconnects, also it is not charging fast, and the controller screen goes dark and the green light stops blinking. The rep thinks the wire has a short in it and needs to be replaced. It was reported that the recharger cord was frayed. The patient reported that while trying to recharge the ins, the controller screen went white and started "screaming at him". The patient took the battery out to get it to stop but when he put the battery back in, it did it again and he had to take it out twice. It was reported that the patient had stopped using stim for a period starting in january. The rep reported that the patient needs to have constant pain coverage for failed spinal surgery, they know it (stimulation therapy) works. They turned stim off in january and more recently turned it back on.

 
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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 Key10309495
MDR Text Key199932803
Report Number3004209178-2020-12637
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 Date04/28/2019
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 Received08/10/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/10/2018
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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