MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE

Model Number 4076

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Insufficient Information (4580)

Event Date 05/18/2011

Event Type  malfunction  

Event Description

This lead was attempted, but not implanted, on (b)(6)2011.There was poor lead.Measurements due to patient condition.After multiple attempts in different atrial position, fixation mechanism failed and lead would not extend/retract.The physician was dr.(b)(6) at (b)(6)hospital.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): MEDTRONIC
• MDR Report Key: 17521325
• MDR Text Key: 321320525
• Report Number: MW5128273
• 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: 06/03/2011

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: 4076
• Patient Sequence Number: 1