MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PLATINIUM

Model Number PLATINIUM SONR CRT-D 1841

Device Problem Reset Problem (3019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/12/2016

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

It was reported that the subject device had been re-initialized one time (on (b)(6) 2016) since the beginning of life.An investigation is required.

Event Description

It was reported that the subject device had been re-initialized one time (on (b)(6) 2016) since the beginning of life.An investigation is required.

• Brand Name: PLATINIUM
• 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: 6141481
• MDR Text Key: 61612401
• Report Number: 1000165971-2016-00779
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2017
• Device Model Number: PLATINIUM SONR CRT-D 1841
• Device Catalogue Number: PLATINIUM SONR CRT-D 1841
• Device Lot Number: S0100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/12/2016
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2015
• 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