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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 Insufficient Information (3190)
Patient Problems Pulmonary Embolism (1498); Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Thrombosis (2100)
Event Date 05/03/2019
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that infection occurred and the ipg system was explanted.During the same procedure, leadless implantable pulse generator (ipg) was implanted but few minutes after the extraction of the introducer, the patient blood pressure dropped and the pulmonary embolism was observed.Patient was in cardiac arrest and cardiopulmonary resuscitation was performed for forty five minutes.Thrombolytic drug was given.The patient's blood pressure and the function of the left ventricle was improved.Physician feels that due to the assumed large size of the pulmonary embolism that the clot may have been from an existing deep vein thrombosis that was embolized during the procedure.It was further reported that the patient died on the same evening, few hours post procedure.Bowel ischemia from cardiac arrest due to pulmonary embolism was determined as a cause of death.
 
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Brand Name
MICRA
Type of Device
INTRODUCER, 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 Key8657966
MDR Text Key146633942
Report Number9612164-2019-02124
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00643169359888
UDI-Public00643169359888
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 05/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/12/2020
Device Model NumberMI2355A
Device Catalogue NumberMI2355A
Device Lot Number00136384
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/03/2019
Initial Date FDA Received05/31/2019
Date Device Manufactured11/13/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age61 YR
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