MAUDE Adverse Event Report: MICROPORT CRM S.R.L. PLATINIUM SONR CRT-D 1811; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number PLATINIUM SONR CRT-D 1811

Device Problem Insufficient Information (3190)

Patient Problem Arrhythmia (1721)

Event Date 11/05/2022

Event Type  Death  

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 microport crm that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, the patient died on his doorstep and the cardiologist (and the patient's family) would like some explanation about why the icd couldn't stop the arythmia he had coming up his stairs.The patient had a severe coronary disease that couldn't be treated by stent, bypass or surgery and was on his second crt (first one on the (b)(6) 2013) so the cardiologist already knows what happened but he would like to have a complete technical analysis for the family.

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 microport crm that was cleared or approved by fda for marketing in the united states.Please refer to the attached analysis report h11.Corrected data: g3.3.Date received by manufacturer changed to (b)(6) 2022 as device investigation received h3 device evaluated by manufacturer?: changed to "yes" as device was received and investigated.

Event Description

Reportedly, the patient died on his doorstep and the cardiologist (and the patient's family) would like some explanation about why the icd couldn't stop the arythmia he had coming up his stairs.The patient had a severe coronary disease that couldn't be treated by stent, bypass or surgery and was on his second crt (first one on the (b)(6) 2013) so the cardiologist already knows what happened but he would like to have a complete technical analysis for the family.

• Brand Name: PLATINIUM SONR CRT-D 1811
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer (Section G): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer Contact: elodie vincent ; via crescentino s.n; saluggia (vc) 13040 ; IT 13040 ; 146013665
• MDR Report Key: 15957494
• MDR Text Key: 305232022
• Report Number: 1000165971-2022-00571
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PLATINIUM SONR CRT-D 1811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Death
• Patient Ethnicity: Non Hispanic