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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 Nausea (1970); Tachycardia (2095); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Event Date 12/04/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported during the implant procedure the leadless implantable pulse generator (ipg) introducer caused a pericardial effsion. It was noted the patient experienced nausea, tachycardia and cardiac tamponade. The effusion was drained. The patient is a participant in the post approval clinical surveillance product surveillance registry. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was further reported that there was no issue with the leadless implantable pulse generator (ipg) or delivery system.
 
Manufacturer Narrative
Corrected: (initial notified date: 04 dec 2019), if information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported during the implant procedure the leadless implantable pulse generator (ipg) introducer, ipg and/ or delivery system caused a pericardial effusion. It was noted the patient experienced nausea, tachycardia and cardiac tamponade. The effusion was drained. The ipg remains in use. The patient is a participant in the post approval clinical surveillance product surveillance registry. 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 Key9443257
MDR Text Key170861865
Report Number9612164-2019-05069
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeFR
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,Followup,Followup
Report Date 02/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/15/2021
Device Model NumberMI2355A
Device Catalogue NumberMI2355A
Device Lot Number00138406
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 Received12/10/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/16/2019
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: 12/10/2019 Patient Sequence Number: 1
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