• 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 Intermittent Continuity (1121); Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Dizziness (2194); Electric Shock (2554)
Event Date 04/02/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 977c165, serial#: (b)(4), implanted: (b)(6) 2018, product type: lead. Other relevant device(s) are: product id: 977c165, serial/lot#: (b)(4), ubd: 27-jul-2022, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) and from a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain. It was reported that on (b)(6) 2019, the patient had a mri of their back for on-going back pain. It was noted it was unknown when the chronic back pain began. A thoracic mri was performed first, and then after waiting 60 minutes, a lumbar mri was performed. During the lumbar mri, the patient felt an electrical shocking sensation that occurred twice during the scan, and was intermittent. The patient had reported to the rep that it did not feel like the ins was on but felt like a shocking sensation where the lead is located. The mri technician confirmed that the patient's controller showed that the patient was full body mri eligible. They used a 1. 5 t closed bore system, however they did not know the coil that was used. The hcp contacted the patient on (b)(6) 2019, and the patient reported doing fine but they had a euphoric sensation from their spine into their brain that was making them feel light-headed and dizzy. The rep was unsure if the symptoms were related to the shocking event that occurred during the mri. It was suggested the patient contact their doctor to assess the symptoms. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the rep. They confirmed that the chronic back pain that the mri was for was not due to a device issue. No further information was provided and additional follow up will be conducted. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the patient on (b)(6) 2019. No other actions were taken to resolve the shocking at the lead site during the mri other than stopping the mri. The device intermittently shuts itself off and/or the stimulation will turn itself up randomly. No further complications were reported/are anticipated.
 
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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8485306
MDR Text Key143371732
Report Number3004209178-2019-06762
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 company representative,consum
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/16/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-