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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL TEMPORARY PACING WIRE; ELECTRODE, PACEMAKER, TEMPORARY
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ST. JUDE MEDICAL TEMPORARY PACING WIRE; ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
Device Problem Positioning Problem (3009)
Patient Problems Cardiac Arrest (1762); Cardiac Perforation (2513); Pericardial Effusion (3271)
Event Type  Death  
Event Description
Medtronic core valve received information that two days post-implant of this bioprosthetic valve, the patient died.It was reported that the procedure was performed under general anesthesia and was uncomplicated.A st.Jude temporary pacing wire was inserted to guard against brady arrhythmia.The patient was monitored in the icu for 48 hours, appeared well and was transferred to a coronary care bed.Late in the day, the patient had a sudden cardiac arrest with no preceding symptoms.Monitoring showed electromechanical dissociation and a paced rhythm with no cardiac output.Resuscitation was commenced and an echo revealed a moderate pericardial effusion with no evidence of tamponade or akinetic ventricles.Pericardiocentesis was performed with no improvement.The patient expired 30 minutes into resuscitative efforts.Additional information was received that autopsy results demonstrated that the pericardium had been perforated by the temporary pacing wire, resulting in cardiac tamponade and patient death.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
TEMPORARY PACING WIRE
Type of Device
ELECTRODE, PACEMAKER, TEMPORARY
Manufacturer (Section D)
ST. JUDE MEDICAL
MDR Report Key17536737
MDR Text Key321043004
Report NumberMW5143621
Device Sequence Number1
Product Code LDF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 08/30/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Patient Sequence Number1
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