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 Problems Bacterial Infection (1735); Sepsis (2067); Heart Failure (2206)

Event Date 03/10/2018

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, the patient was hospitalized on (b)(6) 2018 because of a septicemia associated with heart failure.The icd and the associated (sorin) atrial lead were explanted on (b)(6) 2018.The icd will be returned for analysis.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, the patient was hospitalized on (b)(6) 2018 because of a septicemia associated with heart failure.The crt-d and the associated (sorin) atrial lead were explanted on (b)(6) 2018.The crt-d will be returned for analysis.

Manufacturer Narrative

Preliminary analysis of the returned crt-d did not reveal any anomaly.The device was sterilized and released according to all applicable procedures.

Event Description

Reportedly, the patient was hospitalized on (b)(6) 2018 because of a septicemia associated with heart failure.The crt-d and the associated (sorin) atrial lead were explanted on (b)(6) 2018.The crt-d will 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
• MDR Report Key: 7498327
• MDR Text Key: 107830568
• Report Number: 1000165971-2018-00470
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014425
• UDI-Public: (01)08031527014425(11)160510(17)171210
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2018

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: 12/10/2017
• Device Model Number: PLATINIUM SONR CRT-D 1841
• Device Catalogue Number: PLATINIUM SONR CRT-D 1841
• Device Lot Number: S0178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Distributor Facility Aware Date: 04/17/2018
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 05/07/2018; 06/27/2018
• Supplement Dates FDA Received: 05/31/2018; 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1