FDA Adverse Event
Injury
Summary report: N
HOLDER, HEART-VALVE, PROSTHESIS
MDR report key: 17532608
·
Received August 12, 2023
Report
- Report Number
- MW5139515
- Event Type
- Injury
- Date Received
- August 12, 2023
- Report Date
- March 23, 2018
- Manufacturer
- SORIN
- Product Code
- DTJ
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, COMPLETE HEART BLOCK (CHB) WAS NOTED. TWO DAYS POST VALVE IMPLANT A PERMANENT PACEMAKER WAS IMPLANTED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1085759 | HOLDER, HEART-VALVE, PROSTHESIS | HOLDER, HEART-VALVE, PROSTHESIS | DTJ | SORIN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |