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

Catalog Number TPWUNK

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a temporary pacing on (b)(6) 2022 and suture was used.During the procedure, per user facility medwatch form, mw (b)(4), during a temporary pacing, "ventricular" wire (red connection) fell apart when rn lifted temporary pacemaker (tpm) from patient's chest.Attempt to connect patient to the pacing swan and the pacing swan would not pace.Soft chest compressions initiated until tpw could be reconnected.New pacing wire placed.The device is not available for return.No patient harm was reported.No adverse patient consequences were reported.No additional information was requested.

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Was there any adverse consequence associated with the patient? were there any unexpected outcomes or complications as a result of this issue? was there any change in the patient¿s post operative care due to this issue? what is the current status of the patient? please provide the lot number: this medwatch report is in response to receipt of maude event report: mw (b)(4),.

• Brand Name: TEMPORARY PACING WIRE UNKNOWN PRODUCT
• Type of Device: ELECTRODE, PACEMAKER, TEMP.
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15765319
• MDR Text Key: 307675770
• Report Number: 2210968-2022-09302
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TPWUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male