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

Model Number PLATINIUM SONR CRT-D 1841

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

Patient Problem Cardiomyopathy (1764)

Event Date 10/25/2018

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.Please refer to the attached analysis report.(b)(4).

Event Description

Reportedly, there is an indication of dilated cardiomyopathy for the patient implanted with the subject device.Since this device is subject to the field safety notice issued in (b)(6) 2018, it was prophylactically replaced.

• 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
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 8090526
• MDR Text Key: 128072656
• Report Number: 1000165971-2018-01001
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014425
• UDI-Public: (01)08031527014425(11)160908(17)180408
• 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
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2018
• Device Model Number: PLATINIUM SONR CRT-D 1841
• Device Catalogue Number: PLATINIUM SONR CRT-D 1841
• Device Lot Number: S0214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2018
• Event Location: Hospital
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2016
• 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