MAUDE Adverse Event Report: ST. JUDE MEDICAL RA LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 4086

Device Problem Ambient Noise Problem (2877)

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

Event Type  malfunction  

Event Description

Rep was called to replacement, st.Jude device and boston scientific lead.Ra lead noise noted (b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RA LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17489170
• MDR Text Key: 320697765
• Report Number: MW5121814
• Device Sequence Number: 1
• Product Code: DTB
• 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

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: 4086
• Patient Sequence Number: 1