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 1811

Device Problem Failure to Interrogate (1332)

Patient Problem Pneumonia (2011)

Event Date 10/08/2018

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.

Event Description

Reportedly, after a chest x-ray, the subject icd could not be interrogated on (b)(6) 2018 with two different programmers: an error message was displayed.No anomaly had been observed during the last follow-ups (in (b)(6) and (b)(6) 2018) and in the last remote reports.Ecg showed normal behavior.Preliminary analysis confirmed the reported issue and showed that it was most probably linked to data corruption.Since proper icd functioning could not be guaranteed, the icd was replaced on (b)(6) 2018 following recommendations sent on (b)(6) 2018.

Manufacturer Narrative

Please refer to the attached analysis report.- attachment: [20190225 - file-2018-03269 - analysis_and_closure_report_resp-2019-00212.Pdf].

Event Description

Reportedly, after a chest x-ray, the subject icd could not be interrogated on (b)(6) 2018 with two different programmers: an error message was displayed.No anomaly had been observed during the last follow-ups (in april and june 2018) and in the last remote reports.Ecg showed normal behavior.Preliminary analysis confirmed the reported issue and showed that it was most probably linked to data corruption.Since proper icd functioning could not be guaranteed, the icd was replaced on 12 october 2018 following recommendations sent on(b)(6) 2018.

• 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: 8013476
• MDR Text Key: 125289894
• Report Number: 1000165971-2018-00953
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014388
• UDI-Public: (01)08031527014388(11)170825(17)190325
• 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: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2019
• Device Model Number: PLATINIUM SONR CRT-D 1811
• Device Catalogue Number: PLATINIUM SONR CRT-D 1811
• Device Lot Number: S0276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/08/2018
• Event Location: Hospital
• Date Manufacturer Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1