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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND DEFLECT CATHETER, PERCUTANEOUS

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MEDTRONIC IRELAND DEFLECT CATHETER, PERCUTANEOUS Back to Search Results
Model Number C315HIS02
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Syncope (1610); Dyspnea (1816)
Event Date 02/12/2020
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 implant procedure involving a pacing lead and delivery catheter, the patient suddenly lost consciousness, had difficulty breathing and could not lie flat. The products were removed and the lead was not implanted. The patient required endotracheal intubation and rescue. After that, the patient was stable with normal vital signs. The patient was returned to the ward for monitoring and will wait for elective surgery at a later time. No further patient complications have been reported as a result of this event.

 
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Brand NameDEFLECT
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 Key9792831
MDR Text Key182157767
Report Number9612164-2020-01032
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK101885
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 03/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberC315HIS02
Device Catalogue NumberC315HIS02
Device LOT Number0009722266
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 Received02/12/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/02/2019
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: 03/05/2020 Patient Sequence Number: 1
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