MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE

Model Number 4076

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A call to technical services was made on (b)(6) 2013 stating that this lead was part of the system in which the magnet rate was 85.100 bol and 90 when approximately 1 yr to elective replacement therapy.The output has been 5.0v but they did not think anything had changed in this time period because patient has been in egypt since july.The physician was dr.(b)(6) at (b)(6) medical center in (b)(6).Lead still remains in service.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: 17535606
• MDR Text Key: 321520706
• Report Number: MW5142501
• 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: 06/17/2013

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