FDA Adverse Event
Malfunction
Summary report: N
DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
MDR report key: 17523059
·
Received August 12, 2023
Report
- Report Number
- MW5130007
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- August 30, 2017
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- NVN
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
THIS RA LEAD WAS IMPLANTED ON (B)(6) /2011 AND WAS EXPLANTED ON (B)(6) 2017 DUE TO NOISE. NO OVERSENSING ALLEGATION AGAINST THE LEAD. THE PHYSICIAN WAS DR. JOH(B)(6) N BURKE AT ADVOCATE CHRIST HOSPITAL IN OAK LAWN, IL. NO OTHER INFORMATION IS AVAILABLE. 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 |
|---|---|---|---|---|---|---|---|
| 2234157 | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE | NVN | ST. JUDE MEDICAL | 1882TC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |