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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND MICRA INTRODUCER, CATHETER

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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 Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Event Date 03/03/2022
Event Type  Death  
Manufacturer Narrative
A voluntary medwatch form 3500 was received (report #mw5108345); if information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the attempted implant of a leadless implantable pulse generator (ipg) the right ventricule (rv) was perforated. It was also reported that the patient experienced hypotension and loss of pulses requiring resuscitation. It was also reported that the patient experienced a pericardial effusion that was noted on the echocardiogram and pericardiocentesis was performed. It was also reported that the patient was unable to be resuscitated and died. The cause of death was determined to be cardiac tamponade and perforation at the base of the right atrium (ra) appendage.
 
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Brand NameMICRA
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key14380165
MDR Text Key291588861
Report Number9612164-2022-01792
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,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMI2355A
Device Catalogue NumberMI2355A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/31/2022
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: 05/12/2022 Patient Sequence Number: 1
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