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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); Hemorrhage/Bleeding (1888); Pain (1994); Perforation (2001)
Event Date 09/11/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the attempted implant of a leadless implantable pulse generator (ipg) using the introducer difficulty was encountered advancing the introducer and the patient experienced moderate pain.With some effort without excess pressure the introducer reached the atrium.The guidewire and introducer were removed and the patient went into sudden cardiac arrest/ asystole.Blood pressure was lost and it was not possible to feel a pulse.The patient was in electromechanical dissociation.The physician started cardiopulmonary resuscitation cpr which lasted almost 40 minutes before the patient became stable but unconscious.A dissection of the vena cava was suspected but was not seen during angiography.A computed tomography (ct) scan showed major bleeding/ haemorrhage into the peritoneal (retro and sub) space.Impossible to determine the source of the bleeding.At the time of the ct, the bleeding was stopped.The implant was abandoned and the patient¿s condition is stable.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the attempted implant of a leadless implantable pulse generator (ipg) using the introducer difficulty was encountered advancing the introducer and the patient experienced moderate pain.With some effort without excess pressure the introducer reached the atrium.The guidewire and introducer were removed and the patient went into sudden cardiac arrest/ asystole.Blood pressure was lost and it was not possible to feel a pulse.The patient was in electromechanical dissociation.The physician started cardiopulmonary resuscitation cpr which lasted almost 40 minutes before the patient became stable but unconscious.A dissection of the vena cava was suspected but was not seen during angiography.A computed tomography (ct) scan showed major bleeding/ haemorrhage into the peritoneal (retro and sub) space.Impossible to determine the source of the bleeding.At the time of the ct, the bleeding was stopped.The implant was abandoned and the patient¿s condition is stable.No further patient complications have been reported as a result of this event.
 
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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 Key9075116
MDR Text Key158783286
Report Number9612164-2019-03946
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K132030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberMI2355A
Device Catalogue NumberMI2355A
Device Lot Number00138405
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/17/2019
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) Hospitalization; Life Threatening; Required Intervention;
Patient Age52 YR
Patient Weight35
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