MAUDE Adverse Event Report: ETHICON INC. TEMPORARY CARDIAC PACING WIRE; ELECTRODE, PACEMAKER, TEMP

Catalog Number FEFEP15

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Tamponade (2226); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Date sent to the fda: 10/19/2017.(b)(4).To date the device has not been returned.If the device or further details are received at the later date, a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date, a supplemental medwatch will be sent.Does the surgeon believe that there was any deficiency in the temporary pacing wire? does the surgeon believe the cardiac tamponade was related to the temporary pacing wire? what is the surgeon opinion of the relationship of the hemothorax to the pacing wire removal?.

Event Description

It was reported in a journal article that the patient underwent a ventricular and/or atrial valve cardiac surgery on unknown date and the epicardial temporary pacing wire was inserted.The patient possibly experienced severe complications after wire removal such as tamponade or hemothorax.It was also reported that given the benefits of temporary epicardial pacing and the low incidence of severe complications, this method is still the best way to treat conduction abnormalities following valve surgery.The utility of temporary epicardial pacing wires after coronary bypass remains unclear.Additional information has been reported.

• Brand Name: TEMPORARY CARDIAC PACING WIRE
• Type of Device: ELECTRODE, PACEMAKER, TEMP
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 6962138
• MDR Text Key: 89737142
• Report Number: 2210968-2017-70598
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K980503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FEFEP15
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention