TEO
Report
- Report Number
- 1000165971-2023-00164
- Event Type
- Malfunction
- Date Received
- March 22, 2023
- Date of Event
- March 14, 2023
- Report Date
- March 22, 2023
- Manufacturer
- MICROPORT CRM S.R.L.
- Product Code
- LWP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- 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 MICROPORT CRM THAT WAS CLEARED OR APPROVED BY FDA FOR MARKETING IN THE UNITED STATES.
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.
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.
A FOLLOW-UP 1 OF THIS MFR REPORT: 1000165971-2023-00164 HAS BEEN SENT BY MISTAKE.
CRM-SAL-2023-001. THE PACEMAKER WAS IMPLANTED ON (B)(6) 2022. ON (B)(6) 2022, THE BATTERY IMPEDANCE WAS 370OHMS.
CRM-SAL-2023-001 THE PACEMAKER WAS IMPLANTED ON (B)(6) 2022 ON (B)(6) 2022, THE BATTERY IMPEDANCE WAS 370OHMS.
CRM-SAL-2023-001: THE PACEMAKER WAS IMPLANTED ON (B)(6) 2022, ON (B)(6) 2022, THE BATTERY IMPEDANCE WAS 370OHMS.
CRM-SAL-2023-001: THE PACEMAKER WAS IMPLANTED ON (B)(6) 2022, ON (B)(6) 2022, THE BATTERY IMPEDANCE WAS 370OHMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 436277 | TEO | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | LWP | MICROPORT CRM S.R.L. | TEO DR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |