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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); Tachycardia (2095); Ectopic Heartbeat (4443)
Event Date 01/01/2021
Event Type  Injury  
Event Description
A journal article was reviewed that contained information regarding leadless atrioventricular synchronous pacing in eisenmenger syndrome. The article reports that during the implantation of a leadless implantable pulse generator (ipg), sheath manipulation induced ventricular ectopy which resulted in the loss of an escape rhythm, and required a periprocedural temporary pacemaker. It was also noted that the leadless ipg exhibited atrial undersensing. The device was reprogrammed. The status/disposition of the introducer and device is unknown. No further patient complications have been reported as a result of this event. Further follow up did not yet yield any additional information.
 
Manufacturer Narrative
This information is based entirely on journal literature. Medtronic was made aware of this event through a search of literature publications. This event occurred outside the us. Patient information is limited due to confidentiality concerns. The event only occurred with one patient but specific details on the patient were not provided. The model listed in the report is a representative of the model family, as there is no specific model listed. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: leadless atrioventricular synchronous pacing in eisenmenger syndrome. Heart rhythm case reports. 2021;7:538¿5. Doi. Org/10. 1016/j. Hrcr. 2021. 04. 016. If information is provided in the future, a supplemental report will be issued.
 
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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 Key13443747
MDR Text Key286888357
Report Number9612164-2022-00472
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K132030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2022
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
Date Manufacturer Received01/27/2022
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: 02/03/2022 Patient Sequence Number: 1
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