MAUDE Adverse Event Report: ABBOTT MEDICAL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 7120Q

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 09/19/2022

Event Type  malfunction  

Event Description

Alert: rv bipolar lead impedance warning on (b)(6) 2022.(b)(4).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): ABBOTT MEDICAL
• MDR Report Key: 17488619
• MDR Text Key: 320710919
• Report Number: MW5121318
• 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: 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: 7120Q
• Patient Sequence Number: 1