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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 6250C02
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Heart Failure (2206)
Date of Event 03/28/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that during an implant procedure, the patient experienced heart failure as the catheter was being used and emergency rescue was done.The procedure will be rescheduled when the patient's heart failure is better-controlled.No further patient complications have been reported as a result of this event.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
ATTAIN COMMAND
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
MDR Report Key6627159
Report Number9612164-2017-00707
Device Sequence Number10947534
Product Code DQY
UDI-Device Identifier00613994334831
UDI-Public00613994334831
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K080428
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 03/28/2017
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? No
Operator of Device Health Professional
Device Expiration Date02/09/2018
Device Model Number6250C02
Device Catalogue Number6250C02
Device Lot Number0008156186
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/28/2017
Supplement Date Received by Manufacturer03/28/2017
Initial Report FDA Received Date06/08/2017
Supplement Report FDA Received Date10/03/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age71 YR
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