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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MICRA INTRODUCER, CATHETER

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MEDTRONIC, INC. MICRA INTRODUCER, CATHETER Back to Search Results
Model Number MI2355A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis (2100)
Event Date 10/02/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that two days post-implant of a leadless implantable pulse generator (ipg),the patient experienced deep vein thrombosis. It was noted that endothelial damage from the introducer could be the cause. An anti-coagulant agent was administered for the treatment. The leadless ipg remains in use. 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, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key9255231
MDR Text Key164271472
Report Number2182208-2019-01943
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 10/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMI2355A
Device Catalogue NumberMI2355A
Device Lot NumberUNKNOWN
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 Received10/02/2019
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: 10/30/2019 Patient Sequence Number: 1
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