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

Model Number KORA 250 SR

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

Patient Problems Death (1802); Cardiac Tamponade (2226)

Event Date 10/16/2019

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

Reportedly, the pacing system was implanted on (b)(6) 2019.During the implantation of the associated lead, cardiac tamponade symptoms were observed.Therefore, a drainage treatment was performed.Proper pacemaker functioning was confirmed after the implantation.On (b)(6) 2019, the patient died, most probably because of the reported cardiac tamponade according to the physician.No lead malfunction is suspected.

Event Description

Reportedly, the pacing system was implanted on 16 october 2019.During the implantation of the associated lead, cardiac tamponade symptoms were observed.Therefore, a drainage treatment was performed.Proper pacemaker functioning was confirmed after the implantation.On 17 october 2019, the patient died, most probably because of the reported cardiac tamponade according to the physician.No lead malfunction is suspected.

Manufacturer Narrative

Please refer to the attached analysis report.- attachment: [20200609 - file-2020-00829 - analysis_and_closure_report_resp-2020-00622.Pdf].

Event Description

Reportedly, the pacing system was implanted on 16 october 2019.During the implantation of the associated lead, cardiac tamponade symptoms were observed.Therefore, a drainage treatment was performed.Proper pacemaker functioning was confirmed after the implantation.On (b)(6) 2019, the patient died, most probably because of the reported cardiac tamponade according to the physician.No lead malfunction is suspected.

Manufacturer Narrative

Preliminary analysis revaled that, based on available data, no issue is suspected on the device.

• 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: 9841465
• MDR Text Key: 185747427
• Report Number: 1000165971-2020-00310
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527014593
• UDI-Public: (01)08031527014593(11)180919(17)200919
• 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: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2020
• Device Model Number: KORA 250 SR
• Device Catalogue Number: KORA 250 SR
• Device Lot Number: S0335
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/16/2019
• Event Location: Hospital
• Date Manufacturer Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1