FDA Adverse Event
Injury
Summary report: N
PERMANENT PACEMAKER ELECTRODE
MDR report key: 17525728
·
Received August 12, 2023
Report
- Report Number
- MW5132669
- Event Type
- Injury
- Date Received
- August 12, 2023
- Report Date
- June 1, 2022
- Manufacturer
- UNKNOWN
- Product Code
- DTB
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
PATIENT LIGHTHEADED AND EMERGENCY MEDICAL TECHNICIANS SAID PULSE WAS IN THE 30S NO VENTRICULAR CAPTURE ON ONE BEAT ON THE CURRENT EGM AND TWO BEATS ON THE MAGNET STRIP. DEVICE INDICATES A LEAD WARNING, BUT NO DETAIL ON REPORT, POSSIBLY THE ATRIAL LEAD WHICH IS NOT USED SINCE IT IS VVIR PROGRAMMED. 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 |
|---|---|---|---|---|---|---|---|
| 2244674 | PERMANENT PACEMAKER ELECTRODE | PERMANENT PACEMAKER ELECTRODE | DTB | UNKNOWN | 1388TC-46, 1346T-52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | ST. JUDE MEDICAL DRUG ELUTING PERMANENT RIGHT VENT |