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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 6250V-MP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Pulmonary Edema (2020); Low Oxygen Saturation (2477)
Event Date 10/13/2020
Event Type  Death  
Manufacturer Narrative

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

 
Event Description

It was reported that during the implant procedure the physician was attempting to gain access to the coronary sinus for the left ventricular (lv) lead implant when the patient went into flash pulmonary edema. The patient's blood pressure dropped along with the oxygen saturation. The patient coded and cardiopulmonary resuscitation was administered for about one hour, however, the patient died.

 
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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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10766583
MDR Text Key214073507
Report Number9612164-2020-04176
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number6250V-MP
Device Catalogue Number6250V-MP
Device LOT Number0010346052
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 Received10/13/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/18/2020
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: 10/30/2020 Patient Sequence Number: 1
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