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

MAUDE Adverse Event Report: MEDTRONIC IRELAND 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 IRELAND MICRA INTRODUCER, CATHETER Back to Search Results
Model Number MI2355A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Arrhythmia (1721); Hypoxia (1918); Device Embedded In Tissue or Plaque (3165)
Event Date 12/20/2021
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that, during an attempted implant procedure, after the leadless implantable pulse generator (ipg) introducer was inserted, the patient became hypoxic, sinus rhythm was lost of electrocardiogram (ecg), coronary angiogram showed a possible air embolism and/or plaque and the patient died during the procedure. The leadless ipg introducer was attempted/not used. After ecg rhythm was lost, chest compressions commenced, a heart pump and a temporary pacing wire were used, as some of the rescue attempts. The patient was pronounced dead one hour and 15 minutes later.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMICRA
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway,ie
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway,ie
EI
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key13200984
MDR Text Key283470695
Report Number9612164-2022-00115
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00643169359888
UDI-Public00643169359888
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,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMI2355A
Device Catalogue NumberMI2355A
Device Lot Number00161519
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/20/2021
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: 01/08/2022 Patient Sequence Number: 1
-
-