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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN COMMAND CATHETER, PERCUTANEOUS

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MEDTRONIC IRELAND ATTAIN COMMAND CATHETER, PERCUTANEOUS Back to Search Results
Model Number 6250VIC
Device Problem Break (1069)
Patient Problems Arrhythmia (1721); Left Ventricular Failure (1948); Nausea (1970)
Event Date 03/15/2019
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the patient was having a cardiac resynchronization therapy defibrillator (crt-d) implanted due to heart failure. It was noted that during the implant the guidewire punctured the catheter. It was also noted the patient suddenly suffered from left heart failure and the procedure was stopped. No further patient complications have been reported as a result of this event.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was further reported that the patient developed nausea and an arrhythmia within 2 days of implant. The patient was admitted to the intensive care unit (icu) for treatment.

 
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Brand NameATTAIN COMMAND
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8506687
MDR Text Key141799884
Report Number9612164-2019-01296
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK123153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/23/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/11/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/18/2020
Device MODEL Number6250VIC
Device Catalogue Number6250VIC
Device LOT Number0009286943
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 Received04/22/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/20/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/11/2019 Patient Sequence Number: 1
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