MAUDE Adverse Event Report: UNKNOWN RV LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number SDX65-L5

Device Problems Over-Sensing (1438); Ambient Noise Problem (2877); Protective Measures Problem (3015); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2021

Event Type  malfunction  

Event Description

Rv lead integrity alert triggered on (b)(6) 2021.Sic count of 3,174.Oversenslng noise seen on rvtip to rvring upon initial interrogation and high rate episodes.The patient was admitted to the hospital for lead malfunction.The device tachy therapies were disabled.The rv lead was capped off and new rv defib lead was implanted.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RV LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17524175
• MDR Text Key: 321409451
• Report Number: MW5131122
• 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: 03/20/2022

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: SDX65-L5
• Patient Sequence Number: 1