MAUDE Adverse Event Report: UNKNOWN ATRIAL LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 4087

Device Problem Ambient Noise Problem (2877)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Caller asking want could be causing the vsc episodes to show longer sav intervals that the programmed 90ms sav.Explained to the caller that there appears to be lots of mode switching occurring due to the patient's noisy atrial lead.The caller suspected that there may be a problem with the patient's atrial lead due to all of the noise occurring.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ATRIAL LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17524928
• MDR Text Key: 321409714
• Report Number: MW5131870
• 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
• Report Date: 12/01/2021

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: 4087
• Patient Sequence Number: 1