MAUDE Adverse Event Report: MEDTRONIC, INC.; PERMANENT PACEMAKER ELECTRODE

Model Number 6935M55

Device Problem Material Perforation (2205)

Patient Problem Perforation (2001)

Event Date 02/19/2019

Event Type  malfunction  

Event Description

The device was implanted two months prior to this report without an issue.On follow-up appointment the cardiologist noted lead perforated the myocardium.A subsequent surgery and lead replacement was performed without incident.The patient is doing well.

• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 8427861
• MDR Text Key: 139046306
• Report Number: 8427861
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6935M55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2019
• Date Report to Manufacturer: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25550 DA