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U.S. Department of Health and Human Services

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

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ETHICON INC. TEMPORARY PACING WIRE ELECTRODE, PACEMAKER, TEMP Back to Search Results
Catalog Number TPW32
Device Problems Migration or Expulsion of Device; Appropriate Term/Code Not Available
Event Type  Injury  
Manufacturer Narrative

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? what is the surgeon opinion as the contributing factor to the migration of the temporary pacing wire? was this case previously reported? (b)(4).

 
Event Description

It was reported in a journal article that the patient underwent a 3-vessel coronary artery bypass grafting/cabg procedure in 1999 and the epicardial temporary pacing wire was placed. Three years after, in 2002 the patient experienced ventricular tachycardia and presented with respiratory distress that progressed to full cardiopulmonary arrest requiring intubation. Monomorphic ventricular tachycardia was documented at presentation and the patient was successfully cardioverted to sinus rhythm. The patient was extubated the following day. On day 4 of hospitalization, the patient experienced an episode of near syncope associated with palpitations and was transferred for further evaluation. A transesophageal echocardiogram noted a wire passing through the right atrium, right ventricle, and into the pulmonary artery. Fluoroscopy revealed epicardial temporary pacing wires retained from his cabg operation in 1999 and a wire of the same caliber that appeared to course through the right ventricular outflow tract into the pulmonary artery. The intracardiac position and course of the wire were confirmed with a chest computed tomography scan. The unipolar epicardial pacing wire was extracted and non-sustained monomorphic vt occurred during wire manipulation. Because of the patient¿s left ventricular dysfunction, he was still considered to be at high risk for sudden cardiac death and underwent successful defibrillator implantation. The patient has done well, with no palpitations since discharge. Additional information has been requested.

 
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Brand NameTEMPORARY 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 Key6963245
Report Number2210968-2017-70609
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation HEALTH PROFESSIONAL
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 NumberTPW32
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
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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