MAUDE Adverse Event Report: MEDTRONIC SPRINT QUATTRO SECURE; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 6947

Device Problem Failure to Sense (1559)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was called in to technical services on (b)(6) 2011 that during implant there was no sensing on this lead and the patient had to be externally rescued.The rep is working with dr.(b)(6) at (b)(6) hospital.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SPRINT QUATTRO SECURE
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17516988
• MDR Text Key: 321050724
• Report Number: MW5123937
• 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: 09/01/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 6947
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2023
• Patient Sequence Number: 1