MAUDE Adverse Event Report: ST. JUDE MEDICAL SOLIA S60; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number 377179

Device Problems Product Quality Problem (1506); Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

It was reported that this lead was explanted due to an unknown product performance issue.No additional adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SOLIA S60
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17488902
• MDR Text Key: 320691866
• Report Number: MW5121601
• Device Sequence Number: 1
• Product Code: NVN
• 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: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 377179
• Patient Sequence Number: 1