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U.S. Department of Health and Human Services

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

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ETHICON INC. TEMPORARY CARDIAC PACING WIRE ELECTRODE, PACEMAKER, TEMP Back to Search Results
Catalog Number FEP15
Device Problems Pacing Problem; Appropriate Term/Code Not Available
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.

 
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Brand NameTEMPORARY CARDIAC PACING WIRE
Type of DeviceELECTRODE, 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 Key6963045
Report Number2210968-2017-70606
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
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 Received10/19/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberFEP15
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/19/2017 Patient Sequence Number: 1
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