FDA Adverse Event
Malfunction
Summary report: N
TENDRIL DX
MDR report key: 17516894
·
Received August 11, 2023
Report
- Report Number
- MW5123843
- Event Type
- Malfunction
- Date Received
- August 11, 2023
- Report Date
- September 1, 2011
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- DTB
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
TECHNICAL SERVICES RECEIVED A CALL ON 08/01/2011 FROM SALES REP. IMPEDANCE IS 3K ON THE RA LEAD, THRESHOLD IS UP TO 3V. IS SUPPOSEDLY SENSING OK, IS ONLY AP 1 % OF TIME. PATIENT HAS HAD 15K MODE SWITCHES, THE ONE SHE LOOKED AT IS AS VP (AS), WHERE THERE IS SOME FARFIELD OS IN THE RA. NO PHYSICIAN OR HOSPITAL KNOWN. 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 |
|---|---|---|---|---|---|---|---|
| 763654 | TENDRIL DX | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL | 1388TC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |