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 Problems Intermittent Capture (1080); Impedance Problem (2950)

Patient Problem Seizures (2063)

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

The device model involved in this mdr 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 ventricular lead impedance curve reached 2000 ohms before suddenly decreasing to 600 ohms on (b)(6) 2019.On (b)(6) 2019, the patient suffered from an epileptic seizure of neurological origin, thus his treatment against epilepsy was doubled.The patient underwent an mri on (b)(6) 2019.

Manufacturer Narrative

D3 (email address) corrected.F14 (email address) corrected.G1-2 (first name, last name, email address, phone number) corrected.Preliminary analysis confirmed the reported sudden increase in the ventricular lead impedance curve.The origin of this behavior is unknown.It could result from a lead micro-displacement, a change in the patient medication, an mri scan if the pacing system is not mri compatible; none of them can be confirmed with available data.

Event Description

Reportedly, the ventricular lead impedance curve reached 2000 ohms before suddenly decreasing to 600 ohms on (b)(6) 2019.On (b)(6) 2019, the patient suffered from an epileptic seizure of neurological origin, thus his treatment against epilepsy was doubled.The patient underwent an mri on (b)(6) 2019.

Event Description

Reportedly, the ventricular lead impedance curve reached 2000 ohms before suddenly decreasing to 600 ohms on (b)(6) 2019.On 14 october 2019, the patient suffered from an epileptic seizure of neurological origin, thus his treatment against epilepsy was doubled.The patient underwent an mri on (b)(6) 2019.

Manufacturer Narrative

Please refer to the attached analysis report.- attachment: [20200214 - file-2019-03621 - analysis_and_closure_report_resp-2020-00132.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: 9294630
• MDR Text Key: 174664168
• Report Number: 1000165971-2019-00624
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527012919
• UDI-Public: (01)08031527012919(11)150609(17)170109
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2017
• Device Model Number: KORA 250 DR
• Device Catalogue Number: KORA 250 DR
• Device Lot Number: S0087
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/15/2019
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 01/08/2020; 02/14/2020
• Supplement Dates FDA Received: 01/31/2020; 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1