• 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 Failure to Deliver Energy (1211); Energy Output Problem (1431)
Patient Problems Fall (1848); Device Overstimulation of Tissue (1991); Insufficient Information (4580)
Event Date 10/01/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 97745, serial#: (b)(4), product type: programmer, patient. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient via friend/family member who was implanted with an implantable neurostimulator (ins) for non-malignant pain. It was reported that the controller was not working. The controller battery would show 100% for days, then drop to 50%. They said that for the past week, the controller was at 100% and ins was at 100% even though stimulation was on and the ins battery did not drop to 90% until the day of the report. It was reported that the stimulation would increase and decrease so the patient would get stimulation "way overstimulated" and sometimes not enough. All these issues started in october and they had seen a healthcare provider (hcp) and manufacturer representative who said the internal components were fine. The patient was walking in the kitchen and the stimulation was extremely high so the patient couldn't feel their calves and feet, which made the patient fall and hit their head. It was reported that the controller was the issue.
 
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 Key11174746
MDR Text Key227758949
Report Number3004209178-2021-00818
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,Followup
Report Date 04/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/22/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-