MAUDE Adverse Event Report: ST. JUDE MEDICAL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 7020

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that this right ventricular (rv) lead was associated with a system that exhibited code 1004 and 1006.Additional information from the field indicated surgical intervention was later performed and the rv lead was explanted and replaced.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 17529321
• MDR Text Key: 321408367
• Report Number: MW5136249
• Device Sequence Number: 1
• Product Code: LWS
• 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: 12/06/2021

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: 7020
• Patient Sequence Number: 1