MAUDE Adverse Event Report: MEDTRONIC COVIDIEN MEDTRONIC COVIDIEN FLEXON PACING LEAD; EPICARDIAL PACING WIRES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Arrhythmia (1721); Cardiac Arrest (1762); Cardiac Arrest (1762); Death (1802); Cardiac Tamponade (2226); Cardiac Tamponade (2226)

Event Date 05/20/2019

Event Type  Death  

Event Description

Pt status post coronary artery bypass grafting times four.Post operative day five, pt was being readied to be discharged and epicardial pacing wires discontinued.Shortly thereafter pt complained of not feeling well and became diaphoretic.Hypotension also developed post-wire removal and cardiac rhythm change noted as well.Pt became pulseless and acls was initiated, pulse returned and pt transferred to icu where his chest was opened and epi directly delivered to the heart.Pt was taken to the operating room and washed out / closed chest and returned to icu where he was later diagnosed with anoxic brain injury.Care was withdrawn in collaboration with family on (b)(6) 2019.This event was considered a rare but not unexpected risk after removal of epicardial pacing wires.Our facility experienced another event after removal of pacing wires several weeks later, therefore this event is being reported in tandem with the other event.

• Brand Name: MEDTRONIC COVIDIEN FLEXON PACING LEAD
• Type of Device: EPICARDIAL PACING WIRES
• Manufacturer (Section D): MEDTRONIC COVIDIEN ; minneapolis MN
• MDR Report Key: 8868978
• MDR Text Key: 241261492
• Report Number: 8868978
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 8886258963
• UDI-Public: 88862589-63
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

2 Patient was Involved in the Event

• 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 FDA: 06/12/2019
• Distributor Facility Aware Date: 06/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Weight: 105