• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MICRA INTRODUCER, CATHETER

  • 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, INC. MICRA INTRODUCER, CATHETER Back to Search Results
Model Number MI2355A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Nausea (1970); Vomiting (2144)
Event Date 03/25/2020
Event Type  Injury  
Manufacturer Narrative
This information is based entirely on journal literature. Medtronic was made aware of this event through a search of literature publications. The event only occurred with one patient but specific details on the patient were not provided. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: micra leadless pacemaker retrieval in a pediatric patient. Indian pacing and electrophysiology journal. 2020. 20;132-134. Doi. Org/10. 1016/j. Ipej. 2020. 03. 006. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article was reviewed that contained information regarding a leadless implantable pulse generator (ipg) retrieval in a pediatric patient. The article reports a patient who presented with vomiting and nausea with subsequent bleeding from their left femoral vein site, requiring stitches two days post implant of the leadless ipg. Approximately eight days later, the device exhibited an increase in threshold with a shortened battery longevity. The device also had intermittent loss of capture when the patient turned to their left side and while taking a big breath. The leadless ipg was explanted and replaced. No further patient complications have been reported as a result of this event. Further follow up did not yet yield any additional information.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMICRA
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key11282439
MDR Text Key230434975
Report Number2182208-2021-00516
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMI2355A
Device Catalogue NumberMI2355A
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 Received01/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 02/04/2021 Patient Sequence Number: 1
-
-