MAUDE Adverse Event Report: BIOTRONIK RIGHT ATRIAL LEAD; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number PX53JBP

Device Problems High impedance (1291); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that this right atrial (ra) lead exhibited noise and increased pacing impedance measurements.Surgical intervention was undertaken.The lead was surgically abandoned and replaced.No additional adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RIGHT ATRIAL LEAD
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17531301
• MDR Text Key: 321139939
• Report Number: MW5138216
• Device Sequence Number: 1
• Product Code: NVZ
• 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: 10/12/2021

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: PX53JBP
• Patient Sequence Number: 1