MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE

Model Number 4068

Device Problems Pacing Intermittently (1443); Device Sensing Problem (2917)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/19/2012

Event Type  malfunction  

Event Description

This ra lead was implanted on (b)(6) 1998 and was capped on (b)(6) 2012.The impedance was 190ohms and pacing and sensing were intermittent.The physician was (b)(6).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: 17527088
• MDR Text Key: 321436439
• Report Number: MW5134024
• 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: 08/10/2012

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: 4068
• Patient Sequence Number: 1