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 Missing Test Results (3267)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

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, the p-wave and r-wave amplitude values were not displayed in the patient remote monitoring report.

Event Description

Reportedly, the p-wave and r-wave amplitude values were not displayed in the patient remote monitoring report.

Manufacturer Narrative

Preliminary analysis revealed that p-wave and r-wave amplitude values were not displayed due to a discrepancy between their recording time and the internal implant time.Normal behavior was observed in the following remote monitoring reports.

Event Description

Reportedly, the p-wave and r-wave amplitude values were not displayed in the patient remote monitoring report.

Manufacturer Narrative

Please refer to the attached analysis report.- attachment: [20200612 - file-2020-00714 - analysis_and_closure_report_resp-2020-00621.Pdf].

• 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: 9804526
• MDR Text Key: 185010512
• Report Number: 1000165971-2020-00289
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527014586
• UDI-Public: (01)08031527014586(11)180905(17)200905
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2020
• Device Model Number: KORA 250 DR
• Device Catalogue Number: KORA 250 DR
• Device Lot Number: S0332
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/10/2019
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1