• 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 Material Frayed (1262); Overheating of Device (1437)
Patient Problem Burn(s) (1757)
Event Date 10/16/2020
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: 97755, serial/lot #:(b)(4), udi: 00613994925985. Event date is an estimate (year valid).
 
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain. It was reported that the recharger telemetry module (rtm) cord was frayed where it goes into the paddle, and this frayed portion of the cord as well as the relay box were heating during recharging. The patient has to charge the ins a certain way otherwise they get burned by the hot parts of the rtm, and they reported they had already been burned by the cord which has left marks on their skin from getting burned. A replacement rtm was sent out.
 
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 Key10860045
MDR Text Key216882140
Report Number3004209178-2020-20175
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,Followup,Followup
Report Date 02/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2019
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 Received02/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-