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 Over-Sensing (1438); Pacing Problem (1439)

Patient Problem No Information (3190)

Event Date 11/27/2019

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 subject crt-d was implanted on (b)(6) 2019.The physician reported several episodes of ventricular tachycardia and ventricular fibrillation and one shock during review of the remote follow-up transmitted on (b)(6) 2019 and during the in-clinic follow-up performed on (b)(6) 2019.Sensing of the atrial signals in the ventricular channel was observed since the end of (b)(6) and beginning of (b)(6) when the patient was in atrial fibrillation.Non efficient ventricular pacing was also reported, as well as a decrease of the ventricular lead impedance.During a re-intervention performed on (b)(6) 2019, loose right ventricular lead was reportedly observed on x-ray images, but it remained inside the right ventricle.The right ventricular lead was re-implanted in the apex and a new ventricular lead was implanted in the outflow tract.Preliminary analysis results confirmed the reported behaviors.They most probably resulted from a right ventricular lead positioning issue.

Manufacturer Narrative

The description of the events contained a mistake that has been corrected (field b5).

Event Description

Reportedly, the subject crt-d was implanted on (b)(6) 2019.The physician reported several episodes of ventricular tachycardia and ventricular fibrillation and one shock during review of the remote follow-up transmitted on (b)(6) 2019 and during the in-clinic follow-up performed on (b)(6) 2019.Sensing of the atrial signals in the ventricular channel was observed since the end of october and beginning of november when the patient was in atrial fibrillation.Non efficient ventricular pacing was also reported, as well as a decrease of the ventricular lead impedance.During a re-intervention performed on (b)(6) 2019, loose right ventricular lead was reportedly observed on x-ray images, but it remained inside the right ventricle.Thus, the right ventricular lead (that was implanted in the apex) was explanted and replaced by another one that was implanted in the outflow tract.Preliminary analysis results confirmed the reported behaviors.They most probably resulted from a right ventricular lead positioning issue.

Event Description

Reportedly, the subject crt-d was implanted on (b)(6) 2019.The physician reported several episodes of ventricular tachycardia and ventricular fibrillation and one shock during review of the remote follow-up transmitted on (b)(6) 2019 and during the in-clinic follow-up performed on (b)(6) 2019.Sensing of the atrial signals in the ventricular channel was observed since the end of (b)(6) and beginning of (b)(6) when the patient was in atrial fibrillation.Non efficient ventricular pacing was also reported, as well as a decrease of the ventricular lead impedance.During a re-intervention performed on (b)(6) 2019, loose right ventricular lead was reportedly observed on x-ray images, but it remained inside the right ventricle.Thus, the right ventricular lead (that was implanted in the apex) was explanted and replaced by another one that was implanted in the outflow tract.Preliminary analysis results confirmed the reported behaviors.They most probably resulted from a right ventricular lead positioning issue.

• 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: 9526745
• MDR Text Key: 177565786
• Report Number: 1000165971-2019-00744
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 08031527014425
• UDI-Public: (01)08031527014425(11)190109(17)200809
• 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,Followup
• Report Date: 06/19/2020

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: 08/09/2020
• Device Model Number: PLATINIUM SONR CRT-D 1841
• Device Catalogue Number: PLATINIUM SONR CRT-D 1841
• Device Lot Number: S0348
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/04/2019
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/15/2020; 06/08/2020
• Supplement Dates FDA Received: 01/20/2020; 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1