• 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. ITREL 4 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. ITREL 4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 37703
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Inflammation (1932); Discomfort (2330); Complaint, Ill-Defined (2331)
Event Date 11/12/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_ext, lot#: unknown, product type: extension. Product id: neu _unknown_lead, lot#: unknown, product type: lead. Section d information references the main component of the system. Product id: neu_unknown_ext, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information received from the consumer via healthcare professional (hcp) for a clinical study reported inflammation on the device. Interventions included an explant of the device and extension on (b)(6) 2019 where the device disposition remains unknown. Examination showed that the device was disturbing them and felt that it was a good thing to avoid infection, thus they took out the device with extension. It was reported to be related to the device or therapy. They came for the follow up and told them that there was a dry crust but soft down the skin and for a few weeks, sometimes there was a blood stain on their shirt. A surgeon decided to go in operating room to explore if there was an infection and take out the device and extension to be sure nothing would go to the thalamic lead and space. The surgeon in the pocket put powder of garamycin to be sure with antibiotic to give them. The lead remained still implanted because of the surgeons decision for the patient to go to another hospital who has the ability take the lead out if there was an infection in it. The event remained ongoing. No further complications were reported.
 
Manufacturer Narrative
Product id neu_unknown_ext, lot# unknown, explanted: (b)(6) 2019, product type: extension. Product id neu_unknown_lead, lot# unknown, implanted: (b)(6) 1999, product type: lead. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported due to the skin, the doctor was afraid to the possibility of an infection propagation so decided to explant the device and the extension but not the lead.
 
Manufacturer Narrative
Section 'device' was updated based on additional information received. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the clinical site. A corrected serial number for the neurostimulator that was explanted without replacement was provided.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the clinical site. It was reported that in march they were going to implant the device again.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameITREL 4
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 Key9439712
MDR Text Key180503027
Report Number3004209178-2019-23413
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2020
Device Model Number37703
Device Catalogue Number37703
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 Received07/26/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/29/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/09/2019 Patient Sequence Number: 1
-
-