FDA Adverse Event
Malfunction
Summary report: N
DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
MDR report key: 17525043
·
Received August 12, 2023
Report
- Report Number
- MW5131985
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- March 9, 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 EXHIBITED OVERSENSES OF NOISE THAT RESULTED IN STORAGE OF TWO NON-SUSTAINED VENTRICULAR TACHYCARDIA (NML EPISODES. PACING INHIBITION WAS OBSERVED FOR GREATER THAN 2 SECONDS. THE PHYSICIAN WAS CONSIDERING A LEAD REVISION PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN SERVICE. 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 |
|---|---|---|---|---|---|---|---|
| 563962 | 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 | 2088TC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |