MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY KORA; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number KORA 250 DR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 12/16/2019

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

On (b)(6) 2019, the pacing system was implanted.Reportedly, on (b)(6) 2019, during the tests prior to discharge from the hospital, no anomalies were observed.The patient had sinus node dysfunction.Prior to implantation of the subject pacemaker, the patient had undergone a second mitral valve replacement.On (b)(6) 2019, the patient had a cardiopulmonary arrest and died.The physician suspects that a ventricular fibrillation occurred.

Event Description

On (b)(6) 2019, the pacing system was implanted.Reportedly, on (b)(6) 2019, during the tests prior to discharge from the hospital, no anomalies were observed.The patient had sinus node dysfunction.Prior to implantation of the subject pacemaker, the patient had undergone a second mitral valve replacement.On (b)(6) 2019, the patient had a cardiopulmonary arrest and died.The physician suspects that a ventricular fibrillation occurred.

• Brand Name: KORA
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 9849318
• MDR Text Key: 185746765
• Report Number: 1000165971-2020-00315
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527014586
• UDI-Public: (01)08031527014586(11)181105(17)201101
• 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: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Model Number: KORA 250 DR
• Device Catalogue Number: KORA 250 DR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/16/2019
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1