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U.S. Department of Health and Human Services

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

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ETHICON INC. ETHICON TEMPORARY PACING WIRE ELECTRODE, PACEMAKER, TEMP Back to Search Results
Catalog Number TPW10
Device Problem Migration or Expulsion of Device
Event Type  Injury  
Manufacturer Narrative

(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a 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 patient weakness, lower extremity swelling were related to the temporary pacing wire?.

 
Event Description

It was reported in a journal article that the authors have observed a complication of a migrated epicardial pacing wire found in the right ventricle extending to the pulmonary artery giving rise to shortness of breath. A (b)(6)-old man was admitted for progressive bilateral lower-extremity swelling, weakness, and urinary retention. He underwent uneventful 3-vessel coronary artery bypass grafting (cabg) in 1986. On discharge, right ventricular epicardial pacing wires were cut at the level of skin after an unsuccessful attempt to remove with gentle traction and allowed to retract subcutaneously. On hospital day 2, the patient had shortness of breath. He was found to be tachypneic and wheezing, and was initially treated with a combination ipratropium/albuterol nebulizer with symptomatic relief. On examination, he was found to have a blood oxygen saturation of 93% on room air; his physical examination results were within normal limits. Computed tomography angiography revealed a linear opacity in the left pulmonary artery originating in the right ventricle and terminating in a proximal branch of the left pulmonary artery. Because of the concern of further migration, infection, and perforation of lung parenchyma, the foreign body was electively removed and determined to be an 18-cm segment of a retained transcutaneous epicardial pacing wire which had been inserted 24 years previously when the patient underwent cabg. After extraction, the patient had an uneventful recovery; cultures of the wire showed negative results. It is not clear when the pacing wire became lodged in the pulmonary artery in this case. If it was an acute process during this hospitalization, one cannot be entirely certain that the movement of the wire caused the shortness of breath and wheezing. It could have been an entirely coincidental series of events that led to the identification and removal of the pacing wire. Additional information was requested.

 
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Brand NameETHICON TEMPORARY 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 Key6962774
Report Number2210968-2017-70600
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 NumberTPW10
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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