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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC COVIDIEN MEDTRONIC COVIDIEN FLEXON PACING LEAD; EPICARDIAL PACING WIRES
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MEDTRONIC COVIDIEN MEDTRONIC COVIDIEN FLEXON PACING LEAD; EPICARDIAL PACING WIRES Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Cardiac Arrest (1762)
Event Date 07/03/2019
Event Type  Death  
Event Description
Pt status post coronary artery bypass grafting times two.No post operative complications, readying for discharge and epicardial pacing wires pulled on pod 3, pt almost immediately suffered cardiac arrest and did not recover despite chest re-entry and open cardiac massage immediately after arrest.This event was the second of two events involving death after removal of epicardial pacing wires within days of each other, therefore report was generated for fda and mfr review.
 
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Brand Name
MEDTRONIC COVIDIEN FLEXON PACING LEAD
Type of Device
EPICARDIAL PACING WIRES
Manufacturer (Section D)
MEDTRONIC COVIDIEN
minneapolis MN
MDR Report Key8868966
MDR Text Key153664586
Report Number8868966
Device Sequence Number1
Product Code LDF
UDI-Device Identifier8886258963
UDI-Public88862589-63
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/12/2019
Distributor Facility Aware Date06/04/2019
Event Location Hospital
Date Report to Manufacturer07/12/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age83 YR
Patient Weight91
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