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

Model Number KORA 100 DR

Device Problems Difficult to Interrogate (1331); Pacing Problem (1439); Pacemaker Found in Back-Up Mode (1440)

Patient Problem No Information (3190)

Event Date 05/14/2019

Event Type  malfunction  

Manufacturer Narrative

The device model 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, it was difficult to interrogate the subject pacemaker, which is suspected to have switched in standby mode.Additionally, loss of ventricular pacing was observed.Preliminary analysis revealed that the threshold tests dated (b)(6) 2019 were suspicious of loss of ventricular capture.

Event Description

Reportedly, it was difficult to interrogate the subject pacemaker, which is suspected to have switched in standby mode.Additionally, loss of ventricular pacing was observed.Preliminary analysis revealed that the threshold tests dated 14 may 2019 were suspicious of loss of ventricular capture.

Manufacturer Narrative

Preliminary analysis confirmed that the device was found in standby mode at interrogation for unknown reason.A second switch to standby mode was then requested by the programmer.

Event Description

Reportedly, it was difficult to interrogate the subject pacemaker, which is suspected to have switched in standby mode.Additionally, loss of ventricular pacing was observed.Preliminary analysis revealed that the threshold tests dated (b)(6) 2019 were suspicious of loss of ventricular capture.

• 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: 8666434
• MDR Text Key: 147045763
• Report Number: 1000165971-2019-00336
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527012711
• UDI-Public: (01)08031527012711(11)151019(17)170519
• 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: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2017
• Device Model Number: KORA 100 DR
• Device Catalogue Number: KORA 100 DR
• Device Lot Number: S0121
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/14/2019
• Event Location: Hospital
• Date Manufacturer Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1