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 Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 12/07/2017

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

Reportedly, the warning message "[a3] technical issue on (b)(6) 2017.Defibrillation system potentially ineffective.Contact sorin." was transmitted through remote monitoring report on (b)(6) 2017.Preliminary analysis revealed a potential hardware issue.Recommendations to replace the device were sent on 18 december 2017.The device was explanted on (b)(6) 2017 and should be returned for analysis.

Event Description

Reportedly, the warning message "a3 technical issue on (b)(6) 2017.Defibrillation system potentially ineffective.Contact sorin." was transmitted through remote monitoring report on (b)(6) 2017.Preliminary analysis revealed a potential hardware issue.Recommendations to replace the device were sent on (b)(6) 2017.The device was explanted on (b)(6) 2017 and should be returned for analysis.

• 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: 7147262
• MDR Text Key: 95908367
• Report Number: 1000165971-2017-00959
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014425
• UDI-Public: (01)08031527014425(11)161004(17)180422
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/12/2017

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: 04/22/2018
• Device Model Number: PLATINIUM SONR CRT-D 1841
• Device Catalogue Number: PLATINIUM SONR CRT-D 1841
• Device Lot Number: S0219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/12/2017
• Event Location: Home
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 03/16/2018
• Supplement Dates FDA Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2016
• 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