• 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

  • 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 Back to Search Results
Model Number 97715
Device Problems Overheating of Device (1437); Insufficient Information (3190)
Patient Problem Burn(s) (1757)
Event Date 01/28/2021
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id 97755 lot# serial# (b)(4), product type: recharger. Other relevant device(s) are: product id: 97755, serial/lot #: (b)(4), udi#: (b)(4) date of event: date is approximate. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins). It was reported that they had a recharger (rtm) issue. Pt reported that they are having a lot of problems with the rtm and they have "tried everything" to troubleshoot. Pt explained that the cord going into the paddle is getting hot. Pt reported that because the rtm cord is getting hot, the cord burns the pt's back "a little". The pt was asked if there was a mark left on their skin. Pt confirmed there was a mark left on their skin, but noted they are fine. Pt stated that the issue occurs every other time they use the rtm. Pt confirmed all of these issues started about 6 months ago (year valid), and they called the manufacturer representative (rep) a couple of months ago, on a sunday, to address the issue. Pt stated that after speaking with the rep, the rtm worked "a little bit", but within the last month, the cord getting hot started to become more frequent. An email was sent to the repair department to replace the device. Additional information received from the manufacturer representative. It was reported that they do not recall/remember being notified of this event.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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 Key12373930
MDR Text Key268361139
Report Number3004209178-2021-12977
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 08/26/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/26/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/14/2020
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 Received07/28/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/18/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-