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

Model Number KORA 100 DR

Device Problems Communication or Transmission Problem (2896); Loss of Data (2903)

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

Event Date 06/07/2021

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, on (b)(6) 2021, the reading of the aida arrhythmia events recorded in the pacemaker could not be completed and the pop-up message 'communication error' was displayed many times.The egm could not be read.The position and orientation of the programming head were changed several times but no improvement was observed.All tests (lead impedance, sensing, threshold etc.) could be executed without issue.The user tried to check the arrhythmia events from the patient files at the end of the session but it was not recorded.This issue was not observed with other patients.It occurred only during the last interrogation on this day.It is unknown if the problem is at the device or at the programmer level.

Manufacturer Narrative

D3 and g1 updated.Please refer to the attached analysis report.

Event Description

Reportedly, on 07 june 2021, the reading of the aida arrhythmia events recorded in the pacemaker could not be completed and the pop-up message 'communication error' was displayed many times.The egm could not be read.The position and orientation of the programming head were changed several times but no improvement was observed.All tests (lead impedance, sensing, threshold etc.) could be executed without issue.The user tried to check the arrhythmia events from the patient files at the end of the session but it was not recorded.This issue was not observed with other patients.It occurred only during the last interrogation on this day.It is unknown if the problem is at the device or at the programmer level.

• 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
• MDR Report Key: 12110528
• MDR Text Key: 259980473
• Report Number: 1000165971-2021-00533
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2016
• Device Model Number: KORA 100 DR
• Device Catalogue Number: KORA 100 DR
• Device Lot Number: S0043
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1