MAUDE Adverse Event Report: MEDTRONIC UNKNOWN; PERMANENT PACEMAKER ELECTRODE

Model Number 4074-52

Device Problem Pacing Intermittently (1443)

Patient Problem Heart Block (4444)

Event Type  Injury  

Event Description

This rv lead was implanted on (b)(6) 2001 and was explanted on (b)(6) 2011 due to potential exit block increasing thresholds in a pacer dependent patient.The physician decided to place a new rv lead on the septum for more consistent numbers.The physician was dr.(b)(6) at (b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17520003
• MDR Text Key: 321050021
• Report Number: MW5126951
• 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: 10/06/2011

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: 4074-52
• Patient Sequence Number: 1