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 Pacemaker Found in Back-Up Mode (1440)

Patient Problem Palpitations (2467)

Event Date 07/15/2020

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, when waking up on (b)(6) 2020, the patient felt a pectoral stimulation, though he was fine the day before.Consequently, he was admitted to the hospital.An ecg performed in the morning with a magnet applied on the pacemaker showed ventricular pacing at 70 min-1.Therefore, the patient attended another follow-up at the hospital, in which the pacemaker was implanted, in the afternoon.The pacemaker was found operating in standby mode and re-initialized on the same day.

• 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
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer Contact: laura ouaki ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 146013429
• MDR Report Key: 10331002
• MDR Text Key: 201541723
• Report Number: 1000165971-2020-00530
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527012919
• UDI-Public: (01)08031527012919(11)180702(17)200202
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2020
• Device Model Number: KORA 250 DR
• Device Catalogue Number: KORA 250 DR
• Device Lot Number: S0328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/15/2020
• Event Location: Home
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1