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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 Hematoma (1884); Occlusion (1984); Vascular System (Circulation), Impaired (2572)
Event Date 02/14/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that two weeks post implant procedure of the leadless implantable pulse generator (ipg), the patient experienced increasing pain in both upper legs with barely palpable pulsation in groin region along with absence of peripheral pulsation. Subocclusion of the right iliac artery and artery iliac communis was observed and atheromatosis along distal femoralis communis artery with slight to moderate stenosis was noted. Leadless 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 Key10481450
MDR Text Key205274197
Report Number9612164-2020-03278
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K132030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMI2355A
Device Catalogue NumberMI2355A
Device Lot Number138441
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 Received10/29/2020
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: 09/02/2020 Patient Sequence Number: 1
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