FDA Adverse Event
Malfunction
Summary report: N
DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
MDR report key: 17528626
·
Received August 12, 2023
Report
- Report Number
- MW5135556
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- August 15, 2022
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- NVN
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD, CONNECTED TO THE PACE/SENSE PART OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOWED LOW, OUT OF RANGE PACING IMPEDANCES, AND NOISY SIGNALS OVER SENSING. THE OLD ICD WAS EXPLANTED WITHOUT ALLEGATIONS. THE RV PACE/SENSE PART WAS SURGICALLY ABANDONED AND A BOSTON SCIENTIFIC (BSC) RV LEAD PACE/SENSE SECTION THAT HAD BEEN PREVIOUSLY SURGICALLY ABANDONED WAS CONNECTED TO THE PACE/SENSE PART OF A NEW DEVICE THAT WAS IMPLANTED AT THE SAME PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. 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 |
|---|---|---|---|---|---|---|---|
| 2116959 | 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 | 1888TC | BCG089067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |