MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION

Model Number PLATINIUM 4LV SONR CRT-D 1844

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

Patient Problems Cardiac Arrest (1762); Death (1802); Suffocation (2088)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.

Event Description

On (b)(6) 2018, the defibrillation system was implanted and the device was remotely followed.Reportedly, on (b)(6) 2019, the back-office called the patient because the remote monitoring system was disconnected the day before and was informed that the patient died on (b)(6) 2019.On (b)(6) 2019, the patient went to the hospital in emergency because he was coughing and suffocating.The lungs were found flooded and several tests were performed, such as ultrasounds, x-rays and cat scans.The patient died on (b)(6) 2019.It was reported that the patient suffered a cardiorespiratory arrest and the device did not work properly.Preliminary analysis of the patient files dated until (b)(6) 2019 did not reveal any crt-d anomaly.However, based on the review of the provided patient files, an atrial lead issue and/or lead/crt-d connection issue at atrial level could not be excluded.

Event Description

On 20 march 2018, the defibrillation system was implanted and the device was remotely followed.Reportedly, on (b)(6)2019 , the back-office called the patient because the remote monitoring system was disconnected the day before and was informed that the patient died on(b)(6)2019.On (b)(6)2019 , the patient went to the hospital in emergency because he was coughing and suffocating.The lungs were found flooded and several tests were performed, such as ultrasounds, x-rays and cat scans.The patient died on (b)(6)2019.It was reported that the patient suffered a cardiorespiratory arrest and the device did not work properly.Preliminary analysis of the patient files dated until (b)(6)2019 did not reveal any crt-d anomaly.However, based on the review of the provided patient files, an atrial lead issue and/or lead/crt-d connection issue at atrial level could not be excluded.

Manufacturer Narrative

B5 corrected.Please refer to the attached analysis report.

• Brand Name: PLATINIUM
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, CARDIAC RESYNCHRONIZATION
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; clamart 92140 ; FR 92140
• MDR Report Key: 9456697
• MDR Text Key: 179111203
• Report Number: 1000165971-2019-00696
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014524
• UDI-Public: (01)08031527014524(11)171120(17)190620
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2019
• Device Model Number: PLATINIUM 4LV SONR CRT-D 1844
• Device Catalogue Number: PLATINIUM 4LV SONR CRT-D 1844
• Device Lot Number: S0296
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/18/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 03/16/2020
• Supplement Dates FDA Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1