MAUDE Adverse Event Report: BIOTRONIK PERMANENT PACEMAKER ELECTRODE

Model Number 350973

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported that this right atrial (ra) lead was part of a system revision due to infection.There were no additional adverse patient effects reported.The ra lead was explanted.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERMANENT PACEMAKER ELECTRODE
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): BIOTRONIK
• MDR Report Key: 17537052
• MDR Text Key: 321134684
• Report Number: MW5143934
• 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: 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: 350973
• Patient Sequence Number: 1