MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM RF; DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)

Model Number PARADYM RF SONR CRT-D 9770

Device Problems High impedance (1291); Battery Problem (2885); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Ventricular Fibrillation (2130)

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

The device model involved in this mdr is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.

Event Description

On (b)(6) 2019, the subject device in was found in end of service (eos), with a battery voltage of 1.78v and with high impedance in both coils (>3000ohms).The last charge time was 40s.The device was re-interrogated on (b)(6) 2019.High impedances were still observed.

Event Description

On october 8th 2019, the subject device in was found in end of service (eos), with a battery voltage of 1.78v and with high impedance in both coils (>3000ohms).The last charge time was 40s.The device was re-interrogated on (b)(6) 2019.High impedances were still observed.On (b)(6) 2019, the subject device was explanted and replaced.The right ventricular lead was abandoned and replaced.

• Brand Name: PARADYM RF
• Type of Device: DEFIBRILLATOR, AUTO. IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRO. (CRT-D)
• 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: 9329807
• MDR Text Key: 177174774
• Report Number: 1000165971-2019-00641
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2015
• Device Model Number: PARADYM RF SONR CRT-D 9770
• Device Catalogue Number: PARADYM RF SONR CRT-D 9770
• Device Lot Number: 2815
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/23/2019
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1