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

Catalog Number TPW10

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

Patient Problems Atrial Fibrillation (1729); Myocardial Infarction (1969)

Event Type  Injury  

Manufacturer Narrative

Date sent to the fda: 10/20/2017.(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 myocardial infarction was related to the temporary pacing device? was there a failure to sense or failure to capture or both? were these cases previously reported?.

Event Description

It was reported in a journal article that the patient underwent an isolated coronary artery bypass grafting/cabg procedure on unknown date between (b)(6) 2002 and (b)(6) 2004 and the right and/or left atrial temporary pacing wire was implanted for 72 hours of temporary pacing.There were no serious complications related to atrial pacing or to the implantation and extraction of the leads.It was possible that the patient experienced the incidence of atrial fibrillation.Af was converted to sinus rhythm with intravenous amiodarone and possibly required electrical cardioversion due to hemodynamic instability.No recurrence of af was observed.It was possible that the atrial pacing was discontinued due to loss of atrial sensing and/or pacing capture.The patient possibly experienced a myocardial infarction.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.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 6964717
• MDR Text Key: 89824656
• Report Number: 2210968-2017-70615
• 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: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TPW10
• 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