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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 Tachycardia (2095); Cardiac Tamponade (2226); Cardiac Perforation (2513); Asystole (4442)
Event Date 05/05/2021
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 the implant procedure of the leadless implantable pulse generator (ipg) non-capture was noted. As the device was being repositioned the patients blood pressure had dropped significantly. Perforation occurred resulting in cardiac tamponade. The physician began performing pericardiocentesis. The physician noticed the patient was do not resuscitate so intervention stopped. The patient then experienced ventricular tachycardia (vt), asystole and had passed away.
 
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Brand NameMICRA
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway,ie MN
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway,ie MN
EI
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key11912036
MDR Text Key253460241
Report Number2182208-2021-02216
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2021
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 Received10/04/2021
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: 06/01/2021 Patient Sequence Number: 1
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