MAUDE Adverse Event Report: MICROPORT CRM S.R.L. KORA 250 DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP IMPLANTABLE PULSE GENERATOR

Model Number KORA 250 DR

Device Problem Unstable Capture Threshold (3269)

Patient Problem Insufficient Information (4580)

Event Date 06/21/2022

Event Type  malfunction  

Event Description

Reportedly, on (b)(6) 2022 the subjected kora 250 dr s/n (b)(4) was explanted due to expected malfunction linked to capturing issue.

Manufacturer Narrative

The device involved in this mdr report is not approved in the united states; however, it is similar to a device that was cleared or approved by fda for marketing in the united states.

Manufacturer Narrative

The device involved in this mdr report is not approved in the united states; however, it is similar to a device that was cleared or approved by fda for marketing in the united states.Please refer to the attached analysis report.

Event Description

Reportedly, on 28 july 2022 the subjected kora 250 dr (b)(6) was explanted due to expected malfunction linked to capturing issue.

• Brand Name: KORA 250 DR
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer (Section G): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer Contact: elodie vincent ; via crescentino s.n; saluggia (vc) 13040 ; IT 13040 ; 146013665
• MDR Report Key: 15155206
• MDR Text Key: 304897888
• Report Number: 1000165971-2022-00349
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KORA 250 DR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Ethnicity: Non Hispanic