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

Model Number 1888TC

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Rv lead warning (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Type of Device: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
• Manufacturer (Section D): ST JUDE MEDICAL
• MDR Report Key: 17488714
• MDR Text Key: 320707409
• Report Number: MW5121413
• 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: 08/01/2022

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: 1888TC
• Patient Sequence Number: 1