MAUDE Adverse Event Report: ETHICON ETHICON; ELECTRODE, PACEMAKER, TEMPORARY

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/22/2022

Event Type  malfunction  

Event Description

Atrial pacing wire broke and the wire was stripped to make it functional.

• Brand Name: ETHICON
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ETHICON; 1000 us highway 202 s.; raritan NJ 08869
• MDR Report Key: 15612089
• MDR Text Key: 301822661
• Report Number: 15612089
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25185 DA
• Patient Sex: Female