MAUDE Adverse Event Report: IPG MFG SWITZERLAND INSYNC III MARQUIS; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number 7279

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 01/14/2007

Event Type  Death  

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

Event Description

It was documented during post-market surveillance of cardiac resynchronization therapy, (crt) devices that the patient complained of feeling poorly at home.The patient subsequently lost consciousness and the patient's family called for an ambulance.On arrival of the emergency services, the patient was in a cardiorespiratory arrest state.Cardiorespiratory resuscitation was administered.On the same day, the patient died.Device interrogation was performed and no ventricular tachycardia or fibrillation could be confirmed.Per the physician, the cause of death was indeterminable.It is unknown whether there is a causal device relationship with the death.No additional information is available.

• Brand Name: INSYNC III MARQUIS
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5480731
• MDR Text Key: 39692827
• Report Number: 9614453-2016-01617
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2009

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2008
• Device Model Number: 7279
• Device Catalogue Number: 7279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2009
• Initial Date FDA Received: 03/04/2016
• Date Device Manufactured: 10/19/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5076-52 LEAD, 694965 LEAD, 4193 LEAD
• Patient Outcome(s): Death
• Patient Age: 00056 YR