• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Electromagnetic Interference (1194); Charging Problem (2892); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 97745, serial#: (b)(4), product type: programmer, patient. Product id: 97745, serial#: (b)(4), product type: programmer, patient. Product id: 97745bp, serial# : (b)(4), product type: accessory. Product id: 97745bp, serial#: (b)(4), product type: accessory. 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 that the patient had an mri and ct scan a month prior to the report and they made sure it was in mri mode. The patient thought the radiation killed the batteries because it wouldn't allow him to operate the equipment inside of him. They clarified that the controller wouldn't turn on the ins. The patient said he needed two batteries for the controllers so he can operate the stimulators. The patient puts the battery packs in the controllers and it wouldn't work. A red triangle saying call the manufacturer appeared. The issue began in the last two weeks of (b)(6). No symptoms or further complications were reported. Additional information received from the patient indicated that since they have had their mri, they can't access their settings unless they put aa batteries in their controller. They repeated that they think the mri killed their controller batteries, and the controllers do not work the li battery packs. Patient services had the patient insert the battery pack to see what message came up. The patient stated that the controller showed memory problem. Patient services reviewed the message and instructed the patient on setting up the controller to get their therapy screen. After doing so, the patient confirmed that the controllers were working as intended. The issue was resolved. No further complications were reported or anticipated. Additional information was received from the patient on (b)(6) 2020. It was reported that the patient thinks the mri and ct scan killed his controller batteries. The patient clarified that he has been only been able to connect to his implantable neurostimulator (ins) with the recharger plugged into his controller, but sees no device found screen without the recharger. Troubleshooting steps carried out during the report didn't resolve the issue; there was a no device found screen without the recharger. Two replacement controllers and lithium battery were sent to the patient. Additional information was received from the patient on (b)(6) 2021. They called back and stated that he got the replacement equipment we sent and he still cant charge. He wanted to meet with a rep but they no longer has a health care professional (hcp). They were emailed them hcp listings to follow up with a doctor/rep.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11367054
MDR Text Key233122082
Report Number3004209178-2021-03091
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 02/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2019
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 Received02/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/04/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-