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

Catalog Number FEP15

Device Problems Pacing Problem (1439); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Cardiac Tamponade (2226); Blood Loss (2597); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(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? was there a failure to sense or failure to capture or both? what pacing mode was being attempted? were the wires re-positioned or replaced? what is the surgeon opinion of causative factors of other complications? what is surgeon opinion of causative factor for the wire to become non functional? were these cases previously reported?.

Event Description

It was reported in a journal article that the patient underwent an atrial or ventricular tew cardiac surgery on unknown date between 12/2011 and 04/2012 and epicardial temporary pacing wire was inserted with the positive electrode in the subcutaneous tissues or one electrode on the epicardium and the other on the pericardium or both of them on the epicardium according to the circumstances.The patient experienced severe complications on temporary pacing wire removal necessitating a surgical intervention, such as tamponade or hemothorax.It was also possible that retained temporary pacing wire occurred for atrial or ventricular tew.The patient possibly experienced one of symptoms such as painful pacing, unpleasant cutaneous tingling when one electrode was inserted in the subcutaneous tissues, right shoulder pain or diaphragmatic stimulation.Failure to pace possibly occurred in atrial or ventricular temporary pacing wire on day 0 or before the fourth postoperative day.Sensitivity deteriorated significantly from the 2nd pod for atrial or ventricular temporary pacing wire.It was possible that pacing was considered necessary but had to be replaced by isoproterenol infusion because of ventricular temporary pacing wire dysfunction or painful stimulation.Otherwise, failure to sense occurred in atrial or ventricular temporary pacing wire.Additional information has been reported.It was also possible that temporary pacing wire was removed on day 4 or 5, or still in place beyond the tenth postoperative day.Additional information has been requested.

• 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: 6963045
• MDR Text Key: 89767591
• Report Number: 2210968-2017-70606
• 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
• Report Date: 09/22/2017

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: FEP15
• 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