KORA
Report
- Report Number
- 1000165971-2023-00144
- Event Type
- Malfunction
- Date Received
- March 15, 2023
- Date of Event
- February 17, 2023
- Report Date
- April 5, 2023
- Manufacturer
- MICROPORT CRM S.R.L.
- Product Code
- LWP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE DEVICE INVOLVED IN THIS MDR REPORT 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.
PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.
KORA 100DR COMING FROM A REPLACEMENT WITH VITATRON LEADS IS SHOWING MORE THAN 3000 OHMS OF ATRIAL LEAD IMPEDANCE WHEN PERFORMING THE TEST BUT THE SENSING, AND THE PACING IS COMPLETELY NORMAL AND NO NOISE OR ARTIFACT IS PRESENT AT THE IN CLINIC FOLLOW UP AND THERE IS NO WAY TO REPRODUCE A DISLODGMENT OR NO CONNECTING ISSUE WITH THE PHYSICAL MOVEMENTS. NO TIME UNTIL REPLACEMENT IS SHOWED ONLY IMPEDANCE 0.4 KOHM.
KORA 100DR COMING FROM A REPLACEMENT WITH VITATRON LEADS IS SHOWING MORE THAN 3000 OHMS OF ATRIAL LEAD IMPEDANCE WHEN PERFORMING THE TEST BUT THE SENSING, AND THE PACING IS COMPLETELY NORMAL AND NO NOISE OR ARTIFACT IS PRESENT AT THE IN CLINIC FOLLOW UP AND THERE IS NO WAY TO REPRODUCE A DISLODGMENT OR NO CONNECTING ISSUE WITH THE PHYSICAL MOVEMENTS. NO TIME UNTIL REPLACEMENT IS SHOWED ONLY IMPEDANCE 0.4 KOHM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 768173 | KORA | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | LWP | MICROPORT CRM S.R.L. | KORA 100 DR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |