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

Model Number 6947

Device Problems Pacing Problem (1439); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that this communicator showed several yellow sending waves.Also a red, call doctor light was discussed.At the report, right ventricular pacing lead, out of range spikes were observed to be linked with two different triggered red alerts.The communicator and the device remain in service.No additional information was obtained from the attempts to the field.No adverse patient effects reported.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): MEDTRONIC
• MDR Report Key: 17525753
• MDR Text Key: 321245900
• Report Number: MW5132694
• 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: 11/05/2021

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: 6947
• Patient Sequence Number: 1