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 Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2021

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, an ablation therapy using 3d electro-anatomical mapping (carto) system was performed from 9:00 to 11:30.The pacing mode was set to safer before the therapy, vvi mode 40 min-1 during the therapy, then safer-r mode 70 min-1 at the end of the therapy.Following the last programming, ap-vs was observed at 90 min-1.The rate response (rr) was turned off, the safer setting were changed; ap-vs rate dropped to 70 min-1.Atrial pacing with the sensors set on twin trace was confirmed by a check of the pre-therapy and post-therapy pacing statistics.In addition, after the change to safer-r mode, a mode switch episode was recorded when atrial pacing was performed from the coronary sinus when using the ablation catheter; the markers ap, ar and vs were observed in this episode.To interrogate the device, carto had to be turned off due to the magnetic field.The detection of magnetic field was not confirmed by the physician.The physician was wondering why the rr was activated (80-90 min-1) since the patient was lying on the operating table, and why the markers ap-ar-vs were observed.

Event Description

Reportedly, on (b)(6) 2021, an ablation therapy using 3delectro-anatomical mapping (carto) system was performed from 9:00 to 11:30.The pacing mode was set to safer before the therapy, vvi mode 40 min-1 during the therapy, then safer-r mode 70 min-1 at the end of the therapy.Following the last programming, ap-vs was observed at 90 min-1.The rate response (rr) was turned off, the safer setting were changed; ap-vs rate dropped to 70 min-1.Atrial pacing with the sensors set on twin trace was confirmed by a check of the pre-therapy and post-therapy pacing statistics.In addition, after the change to safer-r mode, a mode switch episode was recorded when atrial pacing was performed from the coronary sinus when using the ablation catheter; the markers ap, ar and vs were observed in this episode.To interrogate the device, carto had to be turned off due to the magnetic field.The detection of magnetic field was not confirmed by the physician.The physician was wondering why the rr was activated (80-90 min-1) since the patient was lying on the operating table, and why the markers ap-ar-vs were observed.

Manufacturer Narrative

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

• 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: 11507835
• MDR Text Key: 248784457
• Report Number: 1000165971-2021-00352
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 08031527014586
• UDI-Public: (01)08031527014586(11)170313(17)190313
• 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: 07/20/2021

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: 03/13/2019
• Device Model Number: KORA 250 DR
• Device Catalogue Number: KORA 250 DR
• Device Lot Number: S0254
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/18/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1