MAUDE Adverse Event Report: ST. JUDE MEDICAL LEAD; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 1056T

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

Tee done and found to have lead vegetation, patient has bacteremia (strep gallolyticus) and physicians wanted lead extraction and colonoscopy (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LEAD
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17490022
• MDR Text Key: 320698129
• Report Number: MW5122540
• Device Sequence Number: 1
• Product Code: OJX
• 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: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 1056T
• Patient Sequence Number: 1