• 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 Migration or Expulsion of Device (1395); Device Difficult to Program or Calibrate (1496)
Patient Problems Inflammation (1932); Pain (1994); Insufficient Information (4580)
Event Date 12/03/2020
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 patient via manufacturer representative who was implanted with an implantable neurostimulator (ins). It was reported that the patient (pt) saw manufacturer's representative (rep) on (b)(6) 2021 and rep did programming and had him walking ten steps back and forth and told him he was programmed. Patient reported rep could not get the reclining position programmed but when they got home they were able to set the reclining position. Patient reported walking from the healthcare provider office to his car his leg starting buzzing and rep told him to decrease the stimulation. Patient stated he is still having buzzing and he thinks the device was not programmed correctly. Patient stated since the device was implanted he is in pain and agony. Patient stated he is seeing (b)(6) on thursday. Patient asked who has his programming / bilateral setting records.   patient stated he is not happy with the therapy. Patient services (ps) reviewed how adaptive stim feature functions and time a person needs to stay in a position for the implant to remember the setting. Ps reviewed mdt does not have medical records/ setting information and recommend patient consult with his healthcare provider (hcp). Patient stated he spoke with the nurse and nurse shared the same information that ps shared. Ps recommend patient consult with hcp regarding his concerns and questions. Ps sending email to reps. The patient was redirected to their healthcare provider to further address the issue. Additional information was reported that the patient stated either there device moves or there is a good deal of inflammation. At this time the patient would like to have the device removed. The patient noted that the buzzing is believed to be a medical issue and it's out of the loop. The issue has not been resolved at this time.
 
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 Key11680645
MDR Text Key249221986
Report Number3004209178-2021-06181
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 04/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2021
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 Received04/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-