MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE

Model Number 5076

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The lead was attempted not used due to lead would not stay in.No physician or hospital known.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: 17521054
• MDR Text Key: 321283719
• Report Number: MW5128002
• 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: 05/04/2011

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: 5076
• Patient Sequence Number: 1