MAUDE Adverse Event Report: ST. JUDE MEDICAL ELECTRODE, PACEMAKER, TEMPORARY

Model Number 2088

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that this lead was used as a temporary wire and was connected to the explanted bsc device.There were no additional adverse patient effects reported.The lead remains in service.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ELECTRODE, PACEMAKER, TEMPORARY
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17524271
• MDR Text Key: 321423450
• Report Number: MW5131218
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 2088
• Patient Sequence Number: 1