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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 Appropriate Term/Code Not Available (3191)
Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)
Event Date 05/08/2022
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 implant the leadless implantable pulse generator (ipg) exhibited high thresholds after first deployment. After successful withdrawing, the doctor replaced the deployment position and deployed it again. After the second deployment the patient experienced cardiac arrest and the leadless ipg could not capture the myocardium. Rescue cardiopulmonary resuscitation was immediately performed and the patient regained consciousness and the heart rate returned to normal. The leadless ipg was then implanted successfully however, the patient subsequently suffered from "respiratory depression" in the intensive care unit and eventually passed away.
 
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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 Key14547096
MDR Text Key292963843
Report Number9612164-2022-02067
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K132030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMI2355A
Device Catalogue NumberMI2355A
Device Lot Number00161488
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/08/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/06/2021
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: 05/31/2022 Patient Sequence Number: 1
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