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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 Use of Device Problem (1670)
Patient Problems Cardiopulmonary Arrest (1765); Hemorrhage/Bleeding (1888); Shock (2072); Thrombus (2101); Ventricular Fibrillation (2130); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Event Date 05/24/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that immediately after implantation of the leadless implantable pulse generator (ipg), the patient experienced perforation, decreased blood pressure and pericardial effusion, which transitioned into cardiac tamponade, shock and cardio-pulmonary arrest. Pacing failure and undersensing occurred which caused ventricular fibrillation arrythmia which required treatment by electrical defibrillation. Tracheal intubation and percutaneous cardiopulmonary support were started while cardiac massage was provided. Pericardial puncture and drainage were performed, and later a thoracotomy was performed as bleeding reoccurred. A blood clot was observed at the implanting site of the leadless ipg during the thoracotomy procedure, and the right ventricular myocardium was noted to be very fragile. The perforation site was sutured and the leadless ipg remains in use. It is unknown if the leadless pacemaker, delivery system or introducer caused or contributed to the event. No further patient complications have been reported as a result of this event.
 
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Brand NameMICRA
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway,ie
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway,ie
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key8712593
MDR Text Key148436511
Report Number9612164-2019-02437
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K132030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/15/2020
Device Model NumberMI2355A
Device Catalogue NumberMI2355A
Device Lot Number00135000
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 Received05/24/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/16/2018
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: 06/19/2019 Patient Sequence Number: 1
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