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

Model Number KORA 250 DR

Device Problem Pacing Inadequately (1442)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2021

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 microport crm that was cleared or approved by fda for marketing in the united states.

Event Description

Reportedly, during a routine follow-up, the doctor noticed inappropriate spikes when recording the ecg.The doctor called us to interrogate the patient and during the follow-up, everything was normal: proper sensing and capture in the 2 cavities was observed, there was not any particular event in the memories.In addition, when launching the egm on another orchestra plus programmer, no anomaly was observed.There was only one atrial extra systole, which led to atrial pacing where it was not necessary.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, during a routine follow-up, the doctor noticed inappropriate spikes when recording the ecg.The doctor called us to interrogate the patient and during the follow-up, everything was normal: proper sensing and capture in the 2 cavities was observed, there was not any particular event in the memories.In addition, when launching the egm on another orchestra plus programmer, no anomaly was observed.There was only one atrial extra systole, which led to atrial pacing where it was not necessary.

• Brand Name: KORA
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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
• MDR Report Key: 12508072
• MDR Text Key: 272538525
• Report Number: 1000165971-2021-00649
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527012919
• UDI-Public: (01)08031527012919(11)171204(17)190704
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2019
• Device Model Number: KORA 250 DR
• Device Catalogue Number: KORA 250 DR
• Device Lot Number: S0296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2017
• 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